270 pipeline articles
FDA Approves Dyna-hex 4 (chlorhexidine gluconate) for Healthcare Personnel Handwash
FDA approves Dyna-hex 4 for handwashing and skin cleansing.
The FDA approved Dyna-hex 4 (chlorhexidine gluconate) for healthcare personnel handwash, skin wound cleansing, and general skin cleansing. T…
The FDA approved Dyna-hex 4 (chlorhexidine gluconate) for use as a handwash and skin cleanser in healthcare settings. It helps reduce bacter…
FDA Approves Tyruko (natalizumab) for Relapsing Forms of Multiple Sclerosis and Crohn's Disease
FDA approves new drug Tyruko for multiple sclerosis and Crohn's disease.
The FDA approved Tyruko (natalizumab) for relapsing forms of multiple sclerosis and for moderately to severely active Crohn's disease. The d…
The FDA approved Tyruko (natalizumab) to treat relapsing forms of multiple sclerosis and moderately to severely active Crohn's disease in ad…
FDA Approves Furoscix (furosemide) for Edema in Heart Failure and CKD
FDA approves new diuretic Furoscix for heart and kidney patients
The FDA approved Furoscix (furosemide) subcutaneous injection for edema in pediatric patients weighing 43 kg and above and in adults with ch…
The FDA approved Furoscix (furosemide) to treat fluid buildup in adults and children weighing 43 kg or more with chronic heart failure or ki…
FDA Approves Kaletra (lopinavir/ritonavir) for HIV-1 Infection in Adults and Children
FDA approves new HIV drug Kaletra for adults and children.
FDA approved Kaletra (lopinavir/ritonavir) for treatment of HIV-1 infection in adults and pediatric patients 14 days and older, in combinati…
The FDA approved Kaletra (lopinavir/ritonavir) to treat HIV-1 infection in adults and children aged 14 days and older. It is used with other…
FDA Approves Kaletra (lopinavir/ritonavir) for HIV-1 Infection in Patients 14 Days and Older
FDA approves Kaletra to treat HIV in adults and children 14 days and older.
The FDA approved Kaletra (lopinavir/ritonavir) for HIV-1 infection in adults and pediatric patients 14 days and older, in combination with o…
The FDA approved Kaletra (lopinavir/ritonavir) for HIV-1 infection in adults and children as young as 14 days. It is used with other HIV med…
FDA Approves Ziac (bisoprolol/hydrochlorothiazide) for Hypertension
FDA approves Ziac, a new combination pill for high blood pressure.
FDA approved Ziac (bisoprolol fumarate/hydrochlorothiazide) for the management of hypertension. The combination provides additive blood pres…
The FDA approved Ziac, a combination of two blood pressure medicines, for treating hypertension. It is for patients who need more than one d…
FDA Approves Avapro (irbesartan) for Hypertension and Diabetic Nephropathy
FDA approves Avapro to treat high blood pressure and kidney disease in diabetes.
FDA approved Avapro (irbesartan) for hypertension and for diabetic nephropathy in hypertensive type 2 diabetes patients with elevated creati…
The FDA approved Avapro (irbesartan) for high blood pressure and for kidney disease in people with type 2 diabetes. It helps lower blood pre…
FDA Approves Rezdiffra (resmetirom) for Noncirrhotic NASH with Moderate to Advanced Fibrosis
FDA approves new drug Rezdiffra for fatty liver disease with scarring.
The FDA approved Rezdiffra (resmetirom) for adults with noncirrhotic NASH and F2 to F3 fibrosis, to be used with diet and exercise. Approval…
The FDA approved Rezdiffra (resmetirom) for adults with a type of fatty liver disease called NASH that has moderate to advanced scarring. It…
FDA Approves Dyna-hex 2 (chlorhexidine gluconate) for Surgical Hand Scrub and Healthcare Personnel Handwash
FDA approves Dyna-hex 2 antiseptic for surgical hand scrubs and healthcare handwash.
The FDA approved Dyna-hex 2 (chlorhexidine gluconate) for use as a surgical hand scrub and healthcare personnel handwash. It significantly r…
The FDA approved Dyna-hex 2 (chlorhexidine gluconate) as a surgical hand scrub and healthcare handwash to reduce bacteria on hands and forea…
FDA Approves Inrebic (fedratinib) for Intermediate-2 or High-Risk Myelofibrosis
FDA approves new pill Inrebic for rare bone marrow cancer.
The FDA approved Inrebic (fedratinib) for adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis. The recommende…
The FDA approved Inrebic (fedratinib) for adults with a type of bone marrow cancer called myelofibrosis. It is a daily pill for patients wit…
FDA Approves Jakafi (ruxolitinib) for Steroid-Refractory Acute Graft-Versus-Host Disease
FDA approves Jakafi for acute graft-versus-host disease in patients 12 and older.
The FDA approved Jakafi (ruxolitinib) for treatment of steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12…
The FDA approved Jakafi (ruxolitinib) to treat acute graft-versus-host disease (aGVHD) in people aged 12 and older who do not respond to ste…
FDA Approves Vonjo (pacritinib) for Myelofibrosis with Low Platelet Counts
FDA approves new drug Vonjo for rare bone marrow cancer with low platelets.
The FDA approved Vonjo (pacritinib) for adults with intermediate or high-risk primary or secondary myelofibrosis with platelet counts below …
The FDA approved Vonjo (pacritinib) for adults with myelofibrosis who have very low platelet counts. It helps reduce spleen size. This offer…
FDA Approves Augmentin XR (amoxicillin/clavulanate) for Community-Acquired Pneumonia and Acute Bacterial Sinusitis
FDA approves new antibiotic Augmentin XR for pneumonia and sinusitis.
The FDA approved Augmentin XR (amoxicillin/clavulanate potassium extended-release tablets) for community-acquired pneumonia and acute bacter…
The FDA approved Augmentin XR, an extended-release antibiotic, for adults and some children with community-acquired pneumonia or acute bacte…
FDA Approves Augmentin Es-600 (amoxicillin/clavulanate potassium) for Recurrent Acute Otitis Media in Children
FDA approves new antibiotic for ear infections in young children
The FDA approved Augmentin Es-600 (amoxicillin/clavulanate potassium) oral suspension for pediatric patients with recurrent or persistent ac…
The FDA approved Augmentin Es-600, a liquid antibiotic for children with recurring ear infections. It is for kids under 2 or in daycare who …
FDA Approves Augmentin (amoxicillin/clavulanate) for Bacterial Infections
FDA approves Augmentin for bacterial infections including sinusitis and UTIs.
The FDA approved Augmentin (amoxicillin and clavulanate potassium) for lower respiratory tract infections, acute bacterial otitis media, sin…
The FDA approved Augmentin, a combination antibiotic, for several bacterial infections like sinusitis, ear infections, and urinary tract inf…
FDA Approves Ogsiveo (nirogacestat) for Progressing Desmoid Tumors
FDA approves Ogsiveo, first drug for rare desmoid tumors
FDA approved Ogsiveo for adult patients with progressing desmoid tumors who require systemic treatment. Approval based on DeFi trial showing…
The FDA approved Ogsiveo (nirogacestat) for adults with progressing desmoid tumors who need systemic treatment. This is the first drug speci…
FDA Approves Subvenite (lamotrigine) for Epilepsy and Bipolar Disorder
FDA approves Subvenite for epilepsy and bipolar disorder maintenance.
FDA approved Subvenite (lamotrigine) for adjunctive therapy of partial-onset, PGTC, and Lennox-Gastaut seizures in patients aged 2 years and…
The FDA approved Subvenite (lamotrigine) to treat certain types of seizures in adults and children age 2 and older, and to delay mood episod…
FDA Approves Augmentin (amoxicillin/clavulanate) for Bacterial Infections
FDA approves new antibiotic Augmentin for bacterial infections
FDA approved Augmentin (amoxicillin/clavulanate) for lower respiratory tract infections, acute otitis media, sinusitis, skin infections, and…
The FDA approved Augmentin, a combination of amoxicillin and clavulanate, to treat bacterial infections like sinusitis, ear infections, and …
FDA Approves Retevmo (selpercatinib) for RET-Driven Cancers
FDA approves new drug Retevmo for certain lung and thyroid cancers.
FDA approved Retevmo (selpercatinib) for adult and pediatric patients with RET fusion-positive NSCLC, RET-mutant MTC, RET fusion-positive th…
The FDA approved Retevmo (selpercatinib) for adults with a type of lung cancer that has a specific gene change, and for children and adults …
FDA Approves Retevmo (selpercatinib) for RET Fusion-Positive Solid Tumors
FDA approves Retevmo for more cancers with RET gene fusions
The FDA approved Retevmo (selpercatinib) for adult and pediatric patients 2 years and older with RET fusion-positive solid tumors that have …
The FDA approved Retevmo (selpercatinib) for adults and children ages 2 and older with advanced solid tumors that have a RET gene fusion and…
FDA Approves Rocuronium Bromide Injection for Tracheal Intubation and Muscle Relaxation
FDA approves new muscle relaxant Rocuronium Bromide for surgery and breathing support.
FDA approved Rocuronium Bromide Injection as an adjunct to general anesthesia for rapid sequence and routine tracheal intubation, and for sk…
The FDA approved Rocuronium Bromide Injection, a muscle relaxant used during surgery or mechanical ventilation to help with breathing tubes …
FDA Approves Repatha (evolocumab) for Cardiovascular Risk Reduction in Adults
FDA approves Repatha to lower heart risks and bad cholesterol
The FDA approved Repatha (evolocumab) to reduce the risk of major adverse cardiovascular events in adults at increased risk. It is also indi…
The FDA approved Repatha (evolocumab) to reduce the risk of heart attacks, strokes, and other heart problems in high-risk adults. It also lo…
FDA Approves Tegretol (carbamazepine) for Epilepsy and Trigeminal Neuralgia
FDA approves Tegretol to treat seizures and nerve pain.
The FDA approved Tegretol (carbamazepine) for partial seizures with complex symptomatology, generalized tonic-clonic seizures, mixed seizure…
The FDA approved Tegretol (carbamazepine) for certain types of seizures and trigeminal neuralgia, a facial nerve pain condition. It is not f…
FDA Approves Tegretol-XR (carbamazepine) Extended-Release for Epilepsy and Trigeminal Neuralgia
FDA approves Tegretol-XR for seizures and nerve pain.
The FDA approved Tegretol-XR (carbamazepine) extended-release tablets for epilepsy and trigeminal neuralgia. The approval was based on activ…
The FDA approved Tegretol-XR (carbamazepine) extended-release tablets for epilepsy and trigeminal neuralgia pain. This new version is taken …
FDA Approves Tegretol (carbamazepine) for Epilepsy and Trigeminal Neuralgia
FDA approves Tegretol to treat epilepsy and nerve pain
FDA approved Tegretol (carbamazepine) for partial seizures with complex symptomatology, generalized tonic-clonic seizures, mixed seizure pat…
The FDA approved Tegretol (carbamazepine) for epilepsy and trigeminal neuralgia, a type of facial nerve pain. It helps control certain seizu…
FDA Approves Zithromax (azithromycin) for Mild to Moderate Bacterial Infections
FDA approves Zithromax to treat bacterial infections in adults and children.
The FDA approved Zithromax (azithromycin) for mild to moderate infections caused by susceptible bacteria, including acute bacterial exacerba…
The FDA approved Zithromax (azithromycin) for mild to moderate bacterial infections like bronchitis, sinusitis, pneumonia, and ear infection…
FDA Approves Zithromax (azithromycin) for Mild to Moderate Bacterial Infections
FDA approves new antibiotic Zithromax for bacterial infections
The FDA approved Zithromax (azithromycin) for mild to moderate infections caused by susceptible bacteria, including acute bacterial exacerba…
The FDA approved Zithromax (azithromycin) to treat mild to moderate bacterial infections like bronchitis, sinusitis, pneumonia, and skin inf…
FDA Approves Children's Zyrtec Hives (cetirizine) for Hives Relief
FDA approves Children's Zyrtec Hives for itching and hives relief.
The FDA approved Children's Zyrtec Hives (cetirizine) for reducing hives and relieving itching due to urticaria. The product is not intended…
The FDA approved Children's Zyrtec Hives (cetirizine) to relieve hives and itching. It is for ages 6 and older. This drug treats symptoms bu…
FDA Approves Verzenio (abemaciclib) for Early and Advanced Breast Cancer
FDA approves Verzenio for early and advanced breast cancer.
FDA approved Verzenio (abemaciclib) for adjuvant treatment of HR+, HER2-, node-positive early breast cancer at high risk of recurrence, and …
The FDA approved Verzenio (abemaciclib) for two types of breast cancer: early stage with high risk of return, and advanced or metastatic dis…
FDA Approves Zithromax (azithromycin) for Multiple Bacterial Infections
FDA approves Zithromax to treat bacterial infections in adults and children.
The FDA approved Zithromax (azithromycin) for mild to moderate infections including acute bacterial exacerbations of chronic bronchitis, sin…
The FDA approved Zithromax (azithromycin) for mild to moderate bacterial infections like bronchitis, sinusitis, pneumonia, and skin infectio…
FDA Approves Zithromax (azithromycin) for Community-Acquired Pneumonia and Pelvic Inflammatory Disease
FDA approves new injectable antibiotic Zithromax for two serious infections.
The FDA approved Zithromax (azithromycin) for injection for community-acquired pneumonia and pelvic inflammatory disease in adults requiring…
The FDA approved Zithromax (azithromycin) for injection to treat community-acquired pneumonia and pelvic inflammatory disease in adults who …
FDA Approves Leqembi Iqlik (lecanemab) for Alzheimer's Disease
FDA approves new Alzheimer's drug Leqembi Iqlik with flexible dosing options.
FDA approved Leqembi Iqlik (lecanemab) for Alzheimer's disease. Treatment should be initiated in patients with mild cognitive impairment or …
The FDA approved Leqembi Iqlik (lecanemab) for early Alzheimer's disease. It is for people with mild cognitive impairment or mild dementia. …
FDA Approves Gleevec (imatinib) for Multiple Kinase-Driven Cancers
FDA approves Gleevec for several types of cancer and blood disorders.
FDA approved Gleevec (imatinib) for newly diagnosed Ph+ CML in chronic phase, Ph+ CML after interferon failure, Ph+ ALL, MDS/MPD, ASM, HES/C…
The FDA approved Gleevec (imatinib) for many cancers, including certain leukemias, stomach tumors, and skin cancer. This gives patients more…
FDA Approves Sarclisa Escena (isatuximab-irfc) Subcutaneous for Multiple Myeloma
FDA approves new multiple myeloma drug Sarclisa Escena for injection under the skin.
The FDA approved Sarclisa Escena (isatuximab-irfc) subcutaneous injection for multiple myeloma in three combination regimens. It is indicate…
The FDA approved Sarclisa Escena (isatuximab-irfc) for subcutaneous injection to treat multiple myeloma. It can be used in three different d…
FDA Approves Sodium Bicarbonate Injection for Metabolic Acidosis and Urinary Alkalinization
FDA approves sodium bicarbonate injection for acidosis and poisonings.
The FDA approved sodium bicarbonate injection to raise plasma pH in adults and pediatric patients with clinically significant metabolic acid…
The FDA approved a new ready-to-use sodium bicarbonate injection to treat metabolic acidosis and help remove certain drugs in poisoning case…
FDA Approves Padcev (enfortumab vedotin) for Muscle Invasive Bladder Cancer
FDA approves Padcev combination for bladder cancer before and after surgery
FDA approved Padcev (enfortumab vedotin) in combination with pembrolizumab as neoadjuvant and adjuvant treatment for adult patients with mus…
The FDA approved Padcev with pembrolizumab for muscle invasive bladder cancer before and after surgery in patients who cannot take cisplatin…
FDA Approves Tuxarin Er (codeine/chlorpheniramine) for Cough and Upper Respiratory Symptoms
FDA approves new cough medicine Tuxarin Er for adults only.
The FDA approved Tuxarin Er (codeine/chlorpheniramine) for temporary relief of cough and upper respiratory symptoms due to allergy or common…
The FDA approved Tuxarin Er for adults 18 and older to relieve cough and cold symptoms. It combines codeine and chlorpheniramine. This does …
FDA Approves Xelstrym (amphetamine) Transdermal System for ADHD in Adults and Children 6+
FDA approves new ADHD patch Xelstrym for adults and children 6 and older.
The FDA approved Xelstrym, a transdermal amphetamine system, for ADHD in adults and children aged 6 years and older. It is applied 2 hours b…
The FDA approved Xelstrym, a skin patch that delivers amphetamine to treat ADHD. It is for adults and children 6 years and older. This gives…
FDA Approves Ryaltris (olopatadine/mometasone) for Seasonal Allergic Rhinitis
FDA approves new nasal spray Ryaltris for seasonal allergy symptoms
The FDA approved Ryaltris, a combination of olopatadine (H1-receptor inhibitor) and mometasone furoate (corticosteroid), for seasonal allerg…
The FDA approved Ryaltris, a nasal spray that combines an antihistamine and a corticosteroid, for seasonal allergies in adults and teens 12 …
FDA Approves Sporanox (itraconazole) for Blastomycosis, Histoplasmosis, Aspergillosis, and Onychomycosis
FDA approves Sporanox capsules for serious fungal infections and nail fungus.
FDA approved itraconazole capsules for blastomycosis, histoplasmosis, aspergillosis (in patients intolerant/refractory to amphotericin B), a…
The FDA approved Sporanox (itraconazole) capsules to treat fungal infections like blastomycosis, histoplasmosis, and aspergillosis in certai…
FDA Approves Levothyroxine Sodium for Injection for Myxedema Coma
FDA approves injectable thyroid drug for life threatening coma condition
The FDA approved Levothyroxine Sodium for Injection for treatment of myxedema coma. The relative bioavailability between this injectable and…
The FDA approved Levothyroxine Sodium for Injection to treat myxedema coma, a severe form of hypothyroidism. This injectable option helps pa…
FDA Approves Anzupgo (delgocitinib) for Moderate to Severe Chronic Hand Eczema
FDA approves new cream Anzupgo for chronic hand eczema in adults.
The FDA approved Anzupgo (delgocitinib) topical cream for moderate to severe chronic hand eczema in adults with inadequate response to topic…
The FDA approved Anzupgo (delgocitinib) cream for moderate to severe chronic hand eczema in adults who haven't improved with steroid creams.…
FDA Approves Xeljanz XR (tofacitinib) for Multiple Inflammatory Conditions
FDA approves new arthritis and colitis drug Xeljanz XR for adults and children.
The FDA approved Xeljanz XR (tofacitinib) extended-release tablets for adult patients with moderately to severely active rheumatoid arthriti…
The FDA approved Xeljanz XR (tofacitinib) for adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative …
FDA Approves Xeljanz (tofacitinib) for Multiple Inflammatory Conditions
FDA approves new oral drug Xeljanz for arthritis and colitis.
The FDA approved Xeljanz (tofacitinib) tablets and Xeljanz XR extended-release tablets for adults with moderately to severely active rheumat…
The FDA approved Xeljanz (tofacitinib) for adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative col…
FDA Approves Cibinqo (abrocitinib) for Refractory Moderate-to-Severe Atopic Dermatitis
FDA approves new pill Cibinqo for hard-to-treat eczema in adults and teens.
The FDA approved Cibinqo (abrocitinib) for adults and pediatric patients 12 years and older with refractory moderate-to-severe atopic dermat…
The FDA approved Cibinqo (abrocitinib) for moderate-to-severe eczema in people 12 and older when other treatments fail. This new once-daily …
FDA Approves Xeljanz (tofacitinib) for Pediatric Psoriatic Arthritis and Juvenile Idiopathic Arthritis
FDA approves Xeljanz for children with arthritis conditions.
The FDA approved Xeljanz (tofacitinib) for pediatric patients 2 years and older with active psoriatic arthritis or polyarticular course juve…
The FDA approved Xeljanz for children ages 2 and older with psoriatic arthritis or juvenile idiopathic arthritis. This provides a new oral o…
FDA Approves Kisqali (ribociclib) for Adjuvant Treatment of Early Breast Cancer
FDA approves Kisqali to treat early breast cancer at high risk of recurrence.
FDA approved Kisqali (ribociclib) in combination with an aromatase inhibitor for adjuvant treatment of adults with HR-positive, HER2-negativ…
The FDA approved Kisqali (ribociclib) for early breast cancer in patients with HR-positive, HER2-negative stage II or III disease at high ri…
FDA Approves Fetroja (cefiderocol) for Complicated UTIs and Hospital-Acquired Pneumonia
FDA approves new antibiotic Fetroja for serious bacterial infections
The FDA approved Fetroja (cefiderocol) for complicated urinary tract infections (cUTI) including pyelonephritis, and hospital-acquired bacte…
The FDA approved Fetroja (cefiderocol) to treat complicated urinary tract infections and certain pneumonia types in adults. It targets hard-…
FDA Approves Kisqali Femara Co-pack (ribociclib/letrozole) for HR+/HER2- Early and Advanced Breast Cancer
FDA approves Kisqali Femara Co-pack for two types of breast cancer.
The FDA approved Kisqali Femara Co-pack (ribociclib/letrozole) for adjuvant treatment of HR+/HER2- stage II/III early breast cancer at high …
The FDA approved Kisqali Femara Co-pack, a combination of two drugs in one package, for certain adults with HR-positive, HER2-negative breas…
FDA Approves Zyrtec-d 12 Hour (cetirizine/pseudoephedrine) for Allergy Symptoms
FDA approves Zyrtec-d 12 Hour for allergy and sinus relief.
FDA approved Zyrtec-d 12 Hour (cetirizine HCl/pseudoephedrine HCl) for temporary relief of hay fever or upper respiratory allergy symptoms i…
The FDA approved Zyrtec-d 12 Hour, a nonprescription tablet that combines an antihistamine and a decongestant. It treats symptoms like runny…
FDA Approves Zyrtec Allergy (cetirizine) for Hay Fever and Upper Respiratory Allergy Symptoms
FDA approves new melt-in-mouth allergy drug Zyrtec Allergy.
The FDA approved Zyrtec Allergy (cetirizine) 10 mg orally disintegrating tablets for temporary relief of symptoms due to hay fever or other …
The FDA approved Zyrtec Allergy (cetirizine) 10 mg orally disintegrating tablets for hay fever and allergy symptoms. The tablet melts in the…
FDA Approves Xeomin (incobotulinumtoxinA) for Chronic Sialorrhea in Patients 2 Years and Older
FDA approves Xeomin to treat chronic drooling in adults and children
The FDA approved Xeomin (incobotulinumtoxinA) for chronic sialorrhea in patients aged 2 years and older. Dosing is based on body weight in p…
The FDA approved Xeomin (incobotulinumtoxinA) for chronic sialorrhea (drooling) in patients aged 2 and older. It is the first botulinum toxi…
FDA Approves Bicillin C-R (penicillin G benzathine and procaine) for Streptococcal and Pneumococcal Infections
FDA approves new antibiotic Bicillin C-R for certain infections.
The FDA approved Bicillin C-R, a combination of penicillin G benzathine and penicillin G procaine, for moderately severe infections due to s…
The FDA approved Bicillin C-R, a combination penicillin antibiotic, for adults and children with certain bacterial infections like strep thr…
FDA Approves Bicillin L-A (penicillin G benzathine) for Streptococcal Infections and Syphilis
FDA approves Bicillin L-A for certain bacterial infections and prevention.
The FDA approved Bicillin L-A (penicillin G benzathine) for mild-to-moderate upper respiratory streptococcal infections, venereal infections…
The FDA approved Bicillin L-A (penicillin G benzathine) for treating mild-to-moderate infections like strep throat and syphilis, and for pre…
FDA Approves Arikayce (amikacin liposome inhalation suspension) for Refractory MAC Lung Disease
FDA approves new drug Arikayce for hard to treat lung infection.
FDA approved Arikayce for treatment of Mycobacterium avium complex (MAC) lung disease in adults with limited or no alternative options, as p…
The FDA approved Arikayce (amikacin liposome inhalation suspension) for adults with a stubborn lung infection called MAC lung disease. It is…
FDA Approves Romvimza (vimseltinib) for Symptomatic Tenosynovial Giant Cell Tumor
FDA approves new drug Romvimza for rare joint tumor condition.
FDA approved Romvimza (vimseltinib) for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection ma…
The FDA approved Romvimza (vimseltinib) for adults with symptomatic tenosynovial giant cell tumor (TGCT) when surgery would cause severe pro…
FDA Approves Zevtera (ceftobiprole) for Staphylococcus aureus Bloodstream Infections, ABSSSI, and CABP
FDA approves new antibiotic Zevtera for serious bacterial infections.
The FDA approved Zevtera (ceftobiprole) for adult patients with Staphylococcus aureus bloodstream infections (including right-sided infectiv…
The FDA approved Zevtera (ceftobiprole) to treat Staphylococcus aureus bloodstream infections, including endocarditis, skin infections, and …
FDA Approves Sarclisa (isatuximab) for Multiple Myeloma in Three Combinations
FDA approves Sarclisa for multiple myeloma in three drug combinations.
The FDA approved Sarclisa (isatuximab) for adult patients with multiple myeloma in three combination regimens: with pomalidomide and dexamet…
The FDA approved Sarclisa (isatuximab) for multiple myeloma. It is used in three different combinations for patients at various stages of th…
FDA Approves Trelstar (triptorelin) for Advanced Prostate Cancer
FDA approves Trelstar for advanced prostate cancer treatment.
FDA approved Trelstar (triptorelin) for advanced prostate cancer. It is a GnRH agonist administered as intramuscular injection. Dosing sched…
The FDA approved Trelstar (triptorelin) to treat advanced prostate cancer. It lowers testosterone to slow cancer growth. This gives patients…
FDA Approves Trelstar (triptorelin pamoate) for Advanced Prostate Cancer
FDA approves new drug Trelstar for advanced prostate cancer.
The FDA approved Trelstar (triptorelin pamoate) for the treatment of advanced prostate cancer. It is a GnRH agonist administered as a single…
The FDA approved Trelstar (triptorelin pamoate) to treat advanced prostate cancer. It lowers testosterone levels to slow cancer growth. This…
FDA Approves Trelstar (triptorelin pamoate) for Advanced Prostate Cancer
FDA approves Trelstar for advanced prostate cancer treatment.
The FDA approved Trelstar (triptorelin pamoate) for the treatment of advanced prostate cancer. It is a GnRH agonist administered as a single…
The FDA approved Trelstar (triptorelin pamoate) for advanced prostate cancer. It lowers testosterone to slow cancer growth. This gives patie…
FDA Approves Besremi (interferon alfa-2b) for Polycythemia Vera
FDA approves new treatment for rare blood disorder polycythemia vera
The FDA approved Besremi (interferon alfa-2b) for adults with polycythemia vera. It is administered subcutaneously every two weeks, with dos…
The FDA approved Besremi (interferon alfa-2b) for adults with polycythemia vera, a condition where the body makes too many red blood cells. …
FDA Approves Eliquis (apixaban) for Reducing Stroke Risk in Nonvalvular Atrial Fibrillation
FDA approves Eliquis to prevent strokes and treat blood clots.
The FDA approved Eliquis (apixaban) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. It …
The FDA approved Eliquis (apixaban) to reduce stroke risk in people with atrial fibrillation and to treat or prevent blood clots. This pill …
FDA Approves Orserdu (elacestrant) for ESR1-Mutated Advanced Breast Cancer
FDA approves new pill for advanced breast cancer with ESR1 mutation.
FDA approved Orserdu (elacestrant) for postmenopausal women and men with ER+/HER2- advanced or metastatic breast cancer with ESR1 mutations …
The FDA approved Orserdu (elacestrant) for certain advanced breast cancers with an ESR1 mutation. It is for patients whose disease has worse…
FDA Approves Adrenalin (epinephrine) for Anaphylaxis and Septic Shock Hypotension
FDA approves Adrenalin for severe allergic reactions and septic shock.
The FDA approved Adrenalin (epinephrine) for emergency treatment of allergic reactions including anaphylaxis, and to increase mean arterial …
The FDA approved Adrenalin (epinephrine) to treat life-threatening allergic reactions and low blood pressure from septic shock. It is given …
FDA Approves Ibrance (palbociclib) for PIK3CA-Mutated Breast Cancer
FDA approves Ibrance combination for certain advanced breast cancer patients.
The FDA approved Ibrance (palbociclib) in combination with inavolisib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, …
The FDA approved Ibrance (palbociclib) with inavolisib and fulvestrant for adults with a specific type of advanced breast cancer that has a …
FDA Approves Ibrance (palbociclib) for HR-Positive, HER2-Negative Advanced Breast Cancer
FDA approves new drug Ibrance for certain advanced breast cancers.
The FDA approved Ibrance (palbociclib) for HR-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase …
The FDA approved Ibrance (palbociclib) for adults with HR-positive, HER2-negative advanced or metastatic breast cancer. It is used with othe…
FDA Approves Trodelvy (sacituzumab govitecan-hziy) for HR+/HER2- Breast Cancer
FDA approves Trodelvy for a common type of advanced breast cancer.
The FDA approved Trodelvy for unresectable locally advanced or metastatic HR+/HER2- breast cancer after endocrine-based therapy and at least…
The FDA approved Trodelvy for adults with advanced HR-positive, HER2-negative breast cancer who have tried hormone therapy and at least two …
FDA Approves Prolia (denosumab) for Osteoporosis and Bone Loss in Multiple Settings
FDA approves new drug Prolia for osteoporosis and bone loss
FDA approved Prolia (denosumab) for postmenopausal osteoporosis, male osteoporosis, glucocorticoid-induced osteoporosis, and bone loss in me…
The FDA approved Prolia (denosumab) to treat osteoporosis and bone loss in certain patients. It is for postmenopausal women, men with osteop…
FDA Approves Belbuca (buprenorphine) Buccal Film for Severe Persistent Pain
FDA approves Belbuca film for severe pain that needs daily opioid treatment.
FDA approved Belbuca (buprenorphine) buccal film for management of severe and persistent pain requiring an opioid analgesic when alternative…
The FDA approved Belbuca (buprenorphine) buccal film for severe, persistent pain that requires daily, around-the-clock opioid treatment and …
FDA Approves Twirla (levonorgestrel/ethinyl estradiol) Transdermal System for Contraception
FDA approves new birth control patch Twirla for women with lower BMI.
The FDA approved Twirla, a levonorgestrel/ethinyl estradiol transdermal system, for contraception in women with BMI <30 kg/m². Effectiveness…
The FDA approved Twirla, a weekly birth control patch for women with a BMI under 30. It contains hormones to prevent pregnancy. However, it …
FDA Approves Morphine Sulfate Oral Solution for Acute and Chronic Pain
FDA approves new morphine liquid for severe pain in adults and children.
The FDA approved Morphine Sulfate Oral Solution (2 mg/mL and 4 mg/mL) for acute and chronic pain in adults and pediatric patients 2 years an…
The FDA approved Morphine Sulfate Oral Solution for severe pain that requires an opioid and hasn't been helped by other treatments. It comes…
FDA Approves Xtampza ER (oxycodone) for Severe Persistent Pain
FDA approves new long acting painkiller Xtampza ER for severe pain
FDA approved Xtampza ER, an extended-release oxycodone, for severe persistent pain requiring an opioid when alternative options are inadequa…
The FDA approved Xtampza ER, a long acting oxycodone capsule, for severe pain that cannot be managed with other treatments. It is taken ever…
FDA Approves OxyContin (oxycodone) for Severe Pain in Adults and Pediatric Patients
FDA approves new opioid painkiller OxyContin for severe pain.
FDA approved OxyContin (extended-release oxycodone) for management of severe and persistent pain requiring an opioid analgesic in adults and…
The FDA approved OxyContin, a strong opioid painkiller, for severe pain that cannot be managed with other treatments. It is for adults and c…
FDA Approves Morphine Sulfate Tablets for Acute and Chronic Pain
FDA approves morphine sulfate tablets for acute and chronic pain.
The FDA approved Morphine Sulfate Tablets for acute pain in adults and pediatric patients weighing at least 50 kg, and for chronic pain in a…
The FDA approved morphine sulfate tablets for acute pain in adults and children over 50 kg, and chronic pain in adults, when other treatment…
FDA Approves Skyrizi (risankizumab) for Ulcerative Colitis in Adults
FDA approves Skyrizi for adults with moderate to severe ulcerative colitis.
The FDA approved Skyrizi (risankizumab) for moderately to severely active ulcerative colitis in adults. The recommended induction dosage is …
The FDA approved Skyrizi (risankizumab) for adults with moderate to severe ulcerative colitis. It is given as an IV infusion at first, then …
FDA Approves Skyrizi (risankizumab) for Ulcerative Colitis in Adults
FDA approves Skyrizi for ulcerative colitis, a new treatment option.
The FDA approved Skyrizi (risankizumab) for moderately to severely active ulcerative colitis in adults. The approval adds to existing indica…
The FDA approved Skyrizi (risankizumab) for adults with moderate to severe ulcerative colitis. It is given as an IV infusion at first, then …
FDA Approves Rextovy (naloxone) Nasal Spray for Opioid Overdose Emergency Treatment
FDA approves Rextovy nasal spray for emergency opioid overdose treatment.
FDA approved Rextovy (naloxone) 4 mg nasal spray for emergency treatment of known or suspected opioid overdose in adults and pediatric patie…
The FDA approved Rextovy (naloxone hydrochloride) nasal spray for emergency treatment of opioid overdose in adults and children. It is meant…
FDA Approves Alecensa (alectinib) for Adjuvant Treatment of ALK-Positive NSCLC
FDA approves Alecensa for early lung cancer after surgery to reduce recurrence risk.
The FDA approved Alecensa (alectinib) for adjuvant treatment of ALK-positive NSCLC after tumor resection in patients with tumors ≥4 cm or no…
The FDA approved Alecensa (alectinib) for patients with ALK-positive non-small cell lung cancer after surgery, if the tumor was large or had…
FDA Approves Dextrose 5% Injection for Source of Water and Calories
FDA approves Dextrose 5% Injection to provide fluids and calories intravenously.
The FDA approved Dextrose 5% Injection as a source of water and calories for intravenous use. It is indicated for patients requiring fluid a…
The FDA approved Dextrose 5% Injection, a sterile sugar water solution given through a vein. It is used to supply water and calories to pati…
FDA Approves Absorica LD (isotretinoin) for Severe Recalcitrant Nodular Acne
FDA approves new acne drug Absorica LD for severe nodular acne.
FDA approved Absorica LD (isotretinoin) for severe recalcitrant nodular acne in non-pregnant patients aged 12 and older. It is reserved for …
The FDA approved Absorica LD (isotretinoin) for severe nodular acne in patients 12 and older. It is for those who have not improved with oth…
FDA Approves Yervoy (ipilimumab) for Multiple Indications Including Melanoma and Lung Cancer
FDA approves Yervoy for several advanced cancers including melanoma and lung cancer.
The FDA approved Yervoy (ipilimumab) for unresectable or metastatic melanoma, adjuvant melanoma, advanced renal cell carcinoma, MSI-H/dMMR c…
The FDA has approved Yervoy (ipilimumab) for many advanced cancers, including melanoma, lung, kidney, and colon cancers. It is used alone or…
FDA Approves Absorica (isotretinoin) for Severe Recalcitrant Nodular Acne
FDA approves new acne drug Absorica for severe cases
The FDA approved Absorica (isotretinoin) for severe recalcitrant nodular acne in non-pregnant patients 12 years and older. It is reserved fo…
The FDA approved Absorica (isotretinoin) for severe nodular acne in patients 12 and older. It is for those who have not improved with other …
FDA Approves Zyvox (linezolid) for Gram-Positive Infections Including MRSA
FDA approves new antibiotic Zyvox for serious bacterial infections.
FDA approved Zyvox (linezolid) for nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin infections, and va…
The FDA has approved Zyvox (linezolid) to treat serious infections caused by Gram-positive bacteria, including pneumonia and skin infections…
FDA Approves Linezolid Injection for Gram-Positive Infections Including Pneumonia and Skin Infections
FDA approves new antibiotic injection for serious bacterial infections
The FDA approved linezolid injection for nosocomial pneumonia, community-acquired pneumonia, complicated skin infections, and vancomycin-res…
The FDA approved linezolid injection for treating serious infections like pneumonia and skin infections caused by certain bacteria, includin…
FDA Approves Argatroban in Sodium Chloride for Thrombosis in HIT and PCI
FDA approves new blood thinner for patients with rare clotting disorder.
The FDA approved argatroban in sodium chloride injection for prophylaxis or treatment of thrombosis in adult patients with heparin-induced t…
The FDA approved Argatroban in Sodium Chloride injection to prevent or treat blood clots in adults with heparin-induced thrombocytopenia (HI…
FDA Approves Terlivaz (terlipressin) for Hepatorenal Syndrome with Rapid Kidney Function Decline
FDA approves new drug Terlivaz for kidney failure in liver disease patients.
The FDA approved Terlivaz (terlipressin) to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney funct…
The FDA approved Terlivaz (terlipressin) to improve kidney function in adults with hepatorenal syndrome, a serious kidney complication of ci…
FDA Approves Voranigo (vorasidenib) for IDH-Mutant Grade 2 Glioma
FDA approves new targeted drug Voranigo for certain brain tumors.
FDA approved Voranigo (vorasidenib) for adult and pediatric patients 12+ with Grade 2 astrocytoma or oligodendroglioma harboring IDH1/2 muta…
The FDA approved Voranigo (vorasidenib) for adults and children 12+ with Grade 2 astrocytoma or oligodendroglioma that have an IDH1 or IDH2 …
FDA Approves Exdensur for Add-On Maintenance Treatment of Severe Eosinophilic Asthma
FDA approves new long-acting shot Exdensur for severe asthma.
FDA approved Exdensur (IL-5 antagonist) for add-on maintenance treatment of severe eosinophilic asthma in patients aged 12 years and older. …
The FDA approved Exdensur as an add-on treatment for severe asthma in people 12 and older. It is given as a shot every six months. This new …
FDA Approves Fluorescite (fluorescein sodium) for Retinal and Iris Angiography
FDA approves Fluorescite injection for eye imaging tests.
The FDA approved Fluorescite Injection 10% for diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. The adul…
The FDA approved Fluorescite Injection 10% for use in eye imaging tests to examine blood flow in the retina and iris. It helps doctors detec…
FDA Approves Hympavzi (marstacimab) for Routine Prophylaxis in Hemophilia A and B Without Inhibitors
FDA approves Hympavzi to prevent bleeding in hemophilia A and B.
The FDA approved Hympavzi (marstacimab) for routine prophylaxis to prevent or reduce bleeding episodes in patients 12 years and older with h…
The FDA approved Hympavzi (marstacimab) to prevent or reduce bleeding episodes in people 12 and older with hemophilia A or B without inhibit…
FDA Approves Provocholine (methacholine chloride) for Bronchial Airway Hyperreactivity Diagnosis
FDA approves new test to help diagnose asthma in certain patients
The FDA approved Provocholine (methacholine chloride) for diagnosing bronchial airway hyperreactivity in adults and children aged 5 years an…
The FDA approved Provocholine, a drug used in a breathing test to diagnose airway hyperreactivity in people aged 5 and older who may have as…
FDA Approves Vyepti (eptinezumab-jjmr) for Preventive Treatment of Migraine in Adults
FDA approves new migraine prevention drug Vyepti given by IV every 3 months
FDA approved Vyepti (eptinezumab-jjmr) for preventive treatment of migraine in adults. It is a calcitonin gene-related peptide antagonist ad…
The FDA approved Vyepti (eptinezumab-jjmr) to prevent migraines in adults. It is given as an IV infusion every three months. This offers a n…
FDA Approves Epidiolex (cannabidiol) for Seizures Associated with LGS, DS, or TSC
FDA approves new cannabis-based drug for severe epilepsy in children.
FDA approved Epidiolex (cannabidiol) oral solution for seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclero…
The FDA approved Epidiolex, a purified cannabis-derived drug, for seizures in patients aged 1 year and older with Lennox-Gastaut syndrome, D…
FDA Approves Ajovy (fremanezumab) for Preventive Migraine Treatment in Adults and Pediatric Patients
FDA approves Ajovy to prevent migraines in adults and children.
The FDA approved Ajovy (fremanezumab) for preventive treatment of migraine in adults and episodic migraine in pediatric patients aged 6-17 y…
The FDA approved Ajovy (fremanezumab) to prevent migraines in adults and in children ages 6 to 17 who weigh at least 45 kg. It is a monthly …
FDA Approves Emgality (galcanezumab) for Preventive Treatment of Migraine and Episodic Cluster Headache
FDA approves new monthly shot Emgality to prevent migraines and treat cluster headaches.
The FDA approved Emgality (galcanezumab) for preventive treatment of migraine and treatment of episodic cluster headache in adults. In two 6…
The FDA approved Emgality (galcanezumab) to prevent migraines and treat episodic cluster headaches in adults. It is a monthly injection that…
FDA Approves Saxenda (liraglutide) for Weight Management in Adults and Adolescents
FDA approves Saxenda for weight management in adults and teens.
The FDA approved Saxenda (liraglutide) for chronic weight management in adults with obesity or overweight with comorbidities, and in pediatr…
The FDA approved Saxenda (liraglutide) for chronic weight management in adults with obesity or overweight plus a weight-related condition, a…
FDA Approves Furosemide for Edema and Hypertension
FDA approves furosemide to treat fluid buildup and high blood pressure.
The FDA approved furosemide for edema associated with congestive heart failure, cirrhosis, and renal disease, and for hypertension in adults…
The FDA has approved furosemide, a diuretic (water pill), to treat fluid retention in adults and children with heart failure, liver disease,…
FDA Approves Brenzavvy (bexagliflozin) for Type 2 Diabetes Glycemic Control
FDA approves Brenzavvy, a new pill for type 2 diabetes.
The FDA approved Brenzavvy (bexagliflozin), an SGLT2 inhibitor, as an adjunct to diet and exercise to improve glycemic control in adults wit…
The FDA approved Brenzavvy (bexagliflozin) to help lower blood sugar in adults with type 2 diabetes. It is taken once a day with or without …
FDA Approves Farxiga (dapagliflozin) for Chronic Kidney Disease and Heart Failure
FDA approves Farxiga for chronic kidney disease and heart failure.
FDA approved Farxiga (dapagliflozin) to reduce risk of eGFR decline, end-stage kidney disease, cardiovascular death, and heart failure hospi…
The FDA approved Farxiga to treat chronic kidney disease and heart failure in adults. It helps protect the kidneys and heart, even in people…
FDA Approves Steglujan (ertugliflozin/sitagliptin) for Type 2 Diabetes
FDA approves new combination pill for type 2 diabetes
FDA approved Steglujan (ertugliflozin/sitagliptin) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diab…
The FDA approved Steglujan, a pill that combines two diabetes drugs, to help control blood sugar in adults with type 2 diabetes. It is meant…
FDA Approves Steglatro (ertugliflozin) for Type 2 Diabetes Mellitus
FDA approves new diabetes drug Steglatro to lower blood sugar
FDA approved Steglatro (ertugliflozin) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The SG…
The FDA approved Steglatro (ertugliflozin) to improve blood sugar control in adults with type 2 diabetes. It is used along with diet and exe…
FDA Approves Invokana (canagliflozin) for Type 2 Diabetes and Related Conditions
FDA approves Invokana to treat type 2 diabetes and protect heart and kidneys.
FDA approved Invokana (canagliflozin) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. It also…
The FDA has approved Invokana (canagliflozin) for adults with type 2 diabetes. It helps lower blood sugar and reduces risks of heart attack,…
FDA Approves Morphine Sulfate Injection for Severe Pain Requiring Opioid Analgesic
FDA approves morphine injection for severe pain when other treatments fail.
FDA approved Morphine Sulfate Injection for management of pain severe enough to require an opioid analgesic and for which alternative treatm…
The FDA approved Morphine Sulfate Injection, an opioid, for severe pain that requires an opioid and when other treatments are not enough. Th…
FDA Approves Afrezza (insulin human) Inhaled Insulin for Adult Diabetes
FDA approves Afrezza, an inhaled insulin for adults with diabetes.
FDA approved Afrezza, a rapid-acting inhaled human insulin, to improve glycemic control in adults with diabetes. It is administered at the b…
The FDA approved Afrezza, an inhaled insulin powder for adults with diabetes. It is taken at the start of meals using a special inhaler, off…
FDA Approves Ultomiris (ravulizumab-cwvz) for Generalized Myasthenia Gravis
FDA approves Ultomiris for adults with a form of myasthenia gravis.
The FDA approved Ultomiris (ravulizumab-cwvz) for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine recepto…
The FDA approved Ultomiris (ravulizumab-cwvz) for adults with generalized myasthenia gravis who have a specific antibody. This drug helps bl…
FDA Approves Soliris (eculizumab) for Generalized Myasthenia Gravis and NMOSD
FDA approves Soliris for two rare autoimmune diseases.
The FDA approved Soliris (eculizumab) for generalized myasthenia gravis (gMG) in anti-AChR antibody-positive patients aged 6 years and older…
The FDA approved Soliris for generalized myasthenia gravis and neuromyelitis optica spectrum disorder. These are rare conditions where the i…
FDA Approves Truqap (capivasertib) for HR+/HER2- Advanced Breast Cancer with PIK3CA/AKT1/PTEN Alterations
FDA approves new drug Truqap for certain advanced breast cancers.
The FDA approved Truqap (capivasertib) in combination with fulvestrant for HR-positive, HER2-negative advanced or metastatic breast cancer w…
The FDA approved Truqap (capivasertib) with fulvestrant for adults with HR-positive, HER2-negative advanced breast cancer that has specific …
FDA Approves Decnupaz for Blastic Plasmacytoid Dendritic Cell Neoplasm
FDA approves new drug Decnupaz for rare blood cancer BPDCN
FDA approved Decnupaz (decnupaz) for adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). It is a CD123-directed antibo…
The FDA approved Decnupaz for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive blood cancer. This tar…
FDA Approves Feraheme (ferumoxytol) for Iron Deficiency Anemia in Adults
FDA approves new iron drug Feraheme for adults with anemia.
FDA approved Feraheme (ferumoxytol) for iron deficiency anemia in adults who cannot tolerate or have unsatisfactory response to oral iron, o…
The FDA approved Feraheme (ferumoxytol) to treat iron deficiency anemia in adults who cannot take oral iron or have chronic kidney disease. …
FDA Approves Imfinzi (durvalumab) for Resectable NSCLC and Other Indications
FDA approves Imfinzi for multiple cancers including lung and liver.
The FDA approved Imfinzi (durvalumab) for multiple indications including resectable NSCLC, unresectable Stage III NSCLC, LS-SCLC, ES-SCLC, B…
The FDA approved Imfinzi (durvalumab) for several cancers, including lung, liver, bile duct, and stomach cancers. It is used alone or with o…
FDA Approves Tremfya (guselkumab) for Ulcerative Colitis and Crohn's Disease
FDA approves Tremfya for ulcerative colitis and Crohn's disease.
The FDA approved Tremfya (guselkumab) for adults with moderately to severely active ulcerative colitis and Crohn's disease. The approval exp…
The FDA approved Tremfya (guselkumab) for adults with moderate to severe ulcerative colitis or Crohn's disease. It is the first drug of its …
FDA Approves Nexplanon (etonogestrel) for Prevention of Pregnancy for Up to 5 Years
FDA approves Nexplanon implant for long-term birth control up to 5 years.
The FDA approved Nexplanon, a single-rod etonogestrel implant, for prevention of pregnancy in women of reproductive potential for up to 5 ye…
The FDA approved Nexplanon, a small implant placed under the skin of the upper arm, to prevent pregnancy for up to 5 years. It offers a long…
FDA Approves Columvi (glofitamab) for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
FDA approves new drug Columvi for adults with hard-to-treat lymphoma.
The FDA approved Columvi (glofitamab) for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma …
The FDA approved Columvi (glofitamab) for adults with relapsed or refractory diffuse large B-cell lymphoma after two or more treatments. Thi…
FDA Approves Hepzato (melphalan) for Uveal Melanoma with Hepatic Metastases
FDA approves new liver treatment for rare eye cancer that spread to liver.
FDA approved Hepzato (melphalan) as a liver-directed treatment for adult patients with uveal melanoma and unresectable hepatic metastases af…
The FDA approved Hepzato (melphalan) for adults with uveal melanoma that has spread to the liver. It is for patients with limited liver invo…
Xatmep receives FDA approval for pediatric acute lymphoblastic leukemia and polyarticular juvenile idiopathic arthritis
FDA approves Xatmep for pediatric leukemia and arthritis treatment options
The FDA has approved Xatmep for pediatric patients with acute lymphoblastic leukemia or active polyarticular juvenile idiopathic arthritis. …
The FDA has approved Xatmep to treat specific forms of childhood leukemia and arthritis, offering new options for young patients.
FDA Approves Nulibry (cyclic pyranopterin monophosphate) for Molybdenum Cofactor Deficiency Type A
FDA approves first drug for rare genetic disorder MoCD Type A.
FDA approved Nulibry (cyclic pyranopterin monophosphate) to reduce mortality risk in patients with molybdenum cofactor deficiency (MoCD) Typ…
The FDA approved Nulibry to reduce the risk of death in patients with molybdenum cofactor deficiency (MoCD) Type A, a rare genetic disorder …
FDA Approves Jylamvo (methotrexate) for Multiple Neoplastic and Inflammatory Indications
FDA approves Jylamvo, a liquid methotrexate for cancer and arthritis.
The FDA approved Jylamvo (methotrexate) oral solution for acute lymphoblastic leukemia, mycosis fungoides, non-Hodgkin lymphoma, rheumatoid …
The FDA approved Jylamvo (methotrexate) oral solution for several cancers and inflammatory conditions. It treats certain leukemias, lymphoma…
FDA Approves Hepcludex (bulevirtide) for Chronic Hepatitis Delta Virus Infection
FDA approves new drug Hepcludex for chronic hepatitis delta infection.
FDA approved Hepcludex (bulevirtide) for chronic HDV infection in adults without cirrhosis or with compensated cirrhosis. Approval was based…
The FDA approved Hepcludex (bulevirtide) for adults with chronic hepatitis delta virus (HDV) infection who have no or compensated cirrhosis.…
FDA Approves Argatroban in Sodium Chloride for Thrombosis in HIT and PCI
FDA approves new blood thinner for patients with rare clotting disorder.
The FDA approved Argatroban in Sodium Chloride injection for prophylaxis or treatment of thrombosis in adult patients with heparin-induced t…
The FDA approved Argatroban in Sodium Chloride injection to prevent or treat blood clots in adults with heparin-induced thrombocytopenia (HI…
FDA Approves Linzess (linaclotide) for IBS-C, CIC, and Pediatric Functional Constipation
FDA approves Linzess for irritable bowel syndrome and constipation in adults and children.
FDA approved Linzess (linaclotide) for irritable bowel syndrome with constipation in adults and pediatric patients 7 years and older, chroni…
The FDA approved Linzess (linaclotide) for irritable bowel syndrome with constipation in adults and children ages 7 and older, and for chron…
FDA Approves Datroway (datroway) for EGFR-Mutated NSCLC and HR+ Breast Cancer
FDA approves new drug Datroway for two types of advanced cancer.
The FDA approved Datroway for two indications: locally advanced or metastatic EGFR-mutated NSCLC after prior EGFR-directed therapy and plati…
The FDA approved Datroway for two advanced cancers: a type of lung cancer with EGFR mutations and a type of breast cancer that is HR-positiv…
FDA Approves Tofidence (tocilizumab-bavi) for Multiple Inflammatory Conditions and COVID-19
FDA approves new biosimilar drug Tofidence for arthritis and COVID-19.
FDA approved Tofidence (tocilizumab-bavi), an IL-6 receptor antagonist, for rheumatoid arthritis, giant cell arteritis, polyarticular juveni…
The FDA approved Tofidence (tocilizumab-bavi), a biosimilar to tocilizumab, for rheumatoid arthritis, giant cell arteritis, juvenile arthrit…
FDA Approves Fintepla (fenfluramine) for Seizures in Dravet and Lennox-Gastaut Syndromes
FDA approves new drug Fintepla for two rare seizure disorders.
The FDA approved Fintepla (fenfluramine) for seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients aged 2 years a…
The FDA approved Fintepla (fenfluramine) to treat seizures in people aged 2 and older with Dravet syndrome or Lennox-Gastaut syndrome. This …
FDA Approves Children's Claritin (loratadine) for Allergic Rhinitis Symptoms
FDA approves Children's Claritin chewable tablets for allergy relief in kids 2 and older.
The FDA approved Children's Claritin (loratadine) chewable tablets for temporary relief of hay fever or upper respiratory allergy symptoms i…
The FDA approved Children's Claritin (loratadine) chewable tablets for hay fever and allergy symptoms in children ages 2 and older. It treat…
FDA Approves Xyzal Allergy 24hr (levocetirizine) for Hay Fever and Respiratory Allergy Symptoms
FDA approves new over-the-counter allergy drug Xyzal Allergy 24hr
The FDA approved Xyzal Allergy 24hr (levocetirizine) for temporary relief of symptoms due to hay fever or other respiratory allergies, inclu…
The FDA approved Xyzal Allergy 24hr (levocetirizine) for temporary relief of hay fever and other allergy symptoms like runny nose, sneezing,…
FDA Approves Venclexta (venetoclax) for CLL/SLL and AML
FDA approves new drug Venclexta for certain blood cancers
FDA approved Venclexta (venetoclax) for adult patients with CLL or SLL, and in combination with azacitidine, decitabine, or low-dose cytarab…
The FDA approved Venclexta (venetoclax) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It is also a…
FDA Approves Cholbam (cholic acid) for Bile Acid Synthesis Disorders and Peroxisomal Disorders
FDA approves first treatment for rare bile acid disorders.
FDA approved Cholbam (cholic acid) for treatment of bile acid synthesis disorders due to single enzyme defects and as adjunctive treatment f…
The FDA approved Cholbam (cholic acid) for two rare inherited conditions that affect the liver and digestion. This is the first approved the…
FDA Approves Rinvoq Lq (upadacitinib) for Polyarticular Juvenile Idiopathic Arthritis
FDA approves new oral drug Rinvoq Lq for children with arthritis.
The FDA approved Rinvoq Lq (upadacitinib) for patients 2 years and older with active polyarticular juvenile idiopathic arthritis after inade…
The FDA approved Rinvoq Lq (upadacitinib) for children ages 2 and older with active polyarticular juvenile idiopathic arthritis (pJIA) who d…
FDA Approves Tyenne (tocilizumab-aazg) for Multiple Inflammatory Conditions
FDA approves new biosimilar drug Tyenne for arthritis and other conditions.
The FDA approved Tyenne (tocilizumab-aazg), an IL-6 receptor antagonist, for rheumatoid arthritis, giant cell arteritis, polyarticular and s…
The FDA approved Tyenne, a biosimilar to tocilizumab, for several inflammatory conditions including rheumatoid arthritis and giant cell arte…
FDA Approves Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) for HIV-1 Infection
FDA approves new once-daily pill Biktarvy for HIV treatment in adults and children.
The FDA approved Biktarvy, a three-drug combination of bictegravir, emtricitabine, and tenofovir alafenamide, for HIV-1 infection in adults …
The FDA approved Biktarvy, a once-daily pill for HIV-1 infection. It is for adults and children weighing at least 14 kg who are new to treat…
FDA Approves Tyenne (tocilizumab-aazg) for Multiple Indications Including RA and COVID-19
FDA approves new biosimilar drug Tyenne for arthritis and COVID-19
The FDA approved Tyenne (tocilizumab-aazg), a biosimilar to tocilizumab, for multiple indications including rheumatoid arthritis, giant cell…
The FDA has approved Tyenne, a biosimilar to tocilizumab, for several inflammatory conditions and COVID-19. It treats rheumatoid arthritis, …
FDA Approves Onapgo (apomorphine) for Motor Fluctuations in Advanced Parkinson's
FDA approves Onapgo for motor fluctuations in advanced Parkinson's disease.
FDA approved Onapgo (apomorphine hydrochloride) subcutaneous infusion for motor fluctuations in adults with advanced Parkinson's disease. Th…
The FDA approved Onapgo (apomorphine hydrochloride) for adults with advanced Parkinson's disease who have motor fluctuations. It is given as…
FDA Approves Baxfendy (baxfendy) for Hypertension in Adults Not Adequately Controlled
FDA approves new drug Baxfendy to help lower high blood pressure.
FDA approved Baxfendy, an aldosterone synthase inhibitor, for hypertension in adults not adequately controlled on other agents. It is used i…
The FDA approved Baxfendy (baxfendy) for adults with high blood pressure not controlled by other medicines. It is taken with other blood pre…
FDA Approves Herceptin (trastuzumab) for HER2-Overexpressing Breast and Gastric Cancers
FDA approves Herceptin for certain breast and stomach cancers.
The FDA approved Herceptin (trastuzumab) for the treatment of HER2-overexpressing breast cancer (adjuvant and metastatic) and HER2-overexpre…
The FDA approved Herceptin (trastuzumab) for HER2-positive breast cancer and stomach cancer. It targets tumors with high levels of HER2 prot…
FDA Approves Phesgo (pertuzumab, trastuzumab, hyaluronidase) for HER2-Positive Breast Cancer
FDA approves new shot for HER2 positive breast cancer treatment
The FDA approved Phesgo, a fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase for subcutaneous injection, for HER2-positiv…
The FDA approved Phesgo, a new shot for HER2 positive breast cancer. It treats early and metastatic breast cancer. This gives patients a fas…
FDA Approves Herceptin Hylecta (trastuzumab/hyaluronidase) for HER2+ Breast Cancer
FDA approves new shot for HER2 positive breast cancer treatment
FDA approved Herceptin Hylecta, a subcutaneous formulation of trastuzumab with hyaluronidase, for adjuvant and metastatic HER2-overexpressin…
The FDA approved Herceptin Hylecta, a shot for HER2 positive breast cancer. It is given under the skin in minutes instead of an IV drip. Thi…
FDA Approves Mavenclad (cladribine) for Relapsing Forms of Multiple Sclerosis
FDA approves new multiple sclerosis drug Mavenclad for relapsing forms
The FDA approved Mavenclad (cladribine) for relapsing forms of MS, including relapsing-remitting and active secondary progressive disease, i…
The FDA approved Mavenclad (cladribine) for adults with relapsing forms of multiple sclerosis (MS), including relapsing-remitting and active…
FDA Approves Argatroban for Thrombosis in Heparin-Induced Thrombocytopenia
FDA approves Argatroban to treat blood clots in patients with HIT
The FDA approved argatroban for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) and as …
The FDA approved Argatroban to prevent or treat blood clots in adults with heparin-induced thrombocytopenia (HIT), a condition where heparin…
FDA approves nuzyra for community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections in adults
FDA approves nuzyra for treating bacterial infections in adult patients safely
The FDA granted approval for nuzyra to treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections i…
The FDA has approved nuzyra to treat community-acquired bacterial pneumonia and skin infections in adults. This regulatory decision confirms…
FDA Approves Fasenra (benralizumab) for Severe Eosinophilic Asthma and EGPA
FDA approves new drug Fasenra for severe asthma and rare disease.
FDA approved Fasenra (benralizumab) for add-on maintenance treatment of severe eosinophilic asthma in patients aged 6 years and older, and f…
The FDA approved Fasenra (benralizumab) for severe asthma in patients 6 and older, and for a rare condition called EGPA in adults. It works …
FDA Approves Nuzyra (omadacycline) for Community-Acquired Bacterial Pneumonia and ABSSSI
FDA approves new antibiotic Nuzyra for pneumonia and skin infections.
The FDA approved Nuzyra (omadacycline), a tetracycline-class antibacterial, for adult patients with community-acquired bacterial pneumonia (…
The FDA approved Nuzyra (omadacycline) to treat community-acquired bacterial pneumonia and certain skin infections in adults. It is a new op…
FDA Approves Ziextenzo (pegfilgrastim-bmez) for Febrile Neutropenia and Acute Radiation Syndrome
FDA approves new biosimilar drug Ziextenzo to prevent infections in cancer patients.
The FDA approved Ziextenzo (pegfilgrastim-bmez) to decrease febrile neutropenia in patients with non-myeloid malignancies receiving myelosup…
The FDA approved Ziextenzo, a biosimilar to Neulasta, to prevent infections in cancer patients receiving chemotherapy and to treat radiation…
FDA Approves Wezlana (ustekinumab-ttwe) for Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, and Ulcerative Colitis
FDA approves Wezlana, a biosimilar to Stelara, for several inflammatory conditions.
The FDA approved Wezlana (ustekinumab-ttwe), a biosimilar to Stelara, for moderate to severe plaque psoriasis, active psoriatic arthritis, m…
The FDA approved Wezlana (ustekinumab-ttwe), a biosimilar to Stelara, for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcera…
FDA Approves Wezlana (ustekinumab-ttwe) for Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, and Ulcerative Colitis
FDA approves Wezlana, a biosimilar to Stelara, for inflammatory conditions.
The FDA approved Wezlana (ustekinumab-ttwe), a biosimilar to Stelara, for multiple indications including plaque psoriasis, psoriatic arthrit…
The FDA approved Wezlana, a biosimilar to Stelara, for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. It of…
FDA Approves Dextrose 5% Injection for Hydration and Calorie Source
FDA approves dextrose 5% injection for hydration and as drug diluent
FDA approved Dextrose 5% Injection for use as a source of calories and water for hydration in adults and pediatric patients. It is also indi…
The FDA approved Dextrose 5% Injection to provide calories and water for hydration in adults and children. It can also be used to mix with o…
FDA Approves Cardiogen-82 (Rubidium Rb 82) for Myocardial Perfusion PET
FDA approves new heart imaging drug to check blood flow in arteries.
The FDA approved Cardiogen-82, a generator producing Rubidium Chloride Rb 82 Injection, for PET myocardial perfusion imaging in adults with …
The FDA approved Cardiogen-82, a radioactive drug used with PET scans to see blood flow in the heart muscle. It helps doctors evaluate patie…
FDA Approves Abiraterone Acetate (Yonsa) for Metastatic Castration-Resistant Prostate Cancer
FDA approves new prostate cancer drug Yonsa to slow tumor growth.
The FDA approved abiraterone acetate (Yonsa) in combination with methylprednisolone for metastatic castration-resistant prostate cancer. The…
The FDA approved Yonsa (abiraterone acetate) for men with advanced prostate cancer that has spread and stopped responding to hormone therapy…
FDA Approves Inqovi (decitabine/cedazuridine) for Myelodysplastic Syndromes
FDA approves new oral drug Inqovi for certain blood cancers.
FDA approved Inqovi (decitabine 35 mg/cedazuridine 100 mg) for adults with MDS, including CMML and intermediate-1, intermediate-2, and high-…
The FDA approved Inqovi, a pill that combines two drugs, for adults with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia…
FDA approves OPDIVO QVANTIG for multiple advanced cancer indications including renal cell carcinoma and melanoma
FDA approves subcutaneous nivolumab combination for multiple advanced cancers
This FDA approval document grants authorization for OPDIVO QVANTIG, a subcutaneous combination of nivolumab and hyaluronidase, for specified…
The FDA has approved a new subcutaneous form of nivolumab for several advanced cancers, offering a more convenient treatment option for elig…
FDA Approves Tecentriq Hybreza (atezolizumab/hyaluronidase) for Multiple Cancers
FDA approves new shot form of cancer drug Tecentriq Hybreza
The FDA approved Tecentriq Hybreza, a subcutaneous formulation of atezolizumab with hyaluronidase, for multiple indications including NSCLC,…
The FDA approved Tecentriq Hybreza, a new injectable form of the cancer drug atezolizumab, for several types of cancer including lung cancer…
FDA Approves Zerbaxa (ceftolozane/tazobactam) for Complicated Infections and Pneumonia
FDA approves new antibiotic Zerbaxa for serious bacterial infections.
FDA approved Zerbaxa (ceftolozane/tazobactam) for complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI)…
The FDA approved Zerbaxa, a new antibiotic, to treat complicated abdominal and urinary tract infections, as well as hospital-acquired pneumo…
FDA Approves Tecentriq (atezolizumab) for Alveolar Soft Part Sarcoma
FDA approves first drug for rare soft tissue sarcoma in children and adults.
The FDA approved Tecentriq (atezolizumab) for adult and pediatric patients 2 years and older with unresectable or metastatic alveolar soft p…
The FDA approved Tecentriq for alveolar soft part sarcoma (ASPS), a rare cancer that often spreads. This is the first treatment specifically…
FDA approves ticagrelor for multiple indications in cardiology and neurology
Brilinta Now Approved for Stroke Prevention in Three Key Groups
The FDA approved ticagrelor (Brilinta) for patients with ACS, CAD at high risk, and acute ischemic stroke or high-risk TIA. In ACS, it was s…
A widely used heart medication now has FDA approval to prevent first strokes in people with diabetes and to protect against repeat strokes a…
FDA Approves Sodium Thiosulfate Injection for Acute Cyanide Poisoning
FDA approves new treatment for cyanide poisoning emergencies
The FDA approved Sodium Thiosulfate Injection for sequential use with sodium nitrite for treatment of acute cyanide poisoning that is seriou…
The FDA approved Sodium Thiosulfate Injection for treating serious cyanide poisoning. It is used with another drug and supportive care. This…
FDA Approves Siliq (brodalumab) for Moderate to Severe Plaque Psoriasis
FDA approves new drug Siliq for adults with plaque psoriasis
The FDA approved Siliq (brodalumab) for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or photother…
The FDA approved Siliq (brodalumab) for adults with moderate to severe plaque psoriasis who have not responded well to other treatments. Thi…
FDA Approves Sdamlo (amlodipine) for Hypertension and Coronary Artery Disease
FDA approves new blood pressure and heart drug Sdamlo for adults and children.
FDA approved Sdamlo, a calcium channel blocker, for hypertension in adults and children aged 6 years and older, and for coronary artery dise…
The FDA approved Sdamlo (amlodipine) for high blood pressure in adults and children 6 and older, and for certain types of chest pain and hea…
FDA Approves Bizengri (zenocutuzumab) for NRG1 Fusion-Positive NSCLC and Pancreatic Cancer
FDA approves new drug Bizengri for two rare lung and pancreatic cancers.
The FDA has approved Bizengri (zenocutuzumab) for adults with advanced NRG1 fusion-positive non-small cell lung cancer and pancreatic adenoc…
The FDA approved Bizengri for adults with advanced non-small cell lung cancer or pancreatic cancer that has a specific genetic change called…
FDA Approves Adempas (riociguat) for Chronic Thromboembolic and Pulmonary Arterial Hypertension
FDA approves new pill Adempas for two types of high blood pressure in lungs
The FDA approved Adempas (riociguat) for adults with persistent/recurrent CTEPH after surgery or inoperable CTEPH, and for PAH (WHO Group 1)…
The FDA approved Adempas (riociguat) for two forms of pulmonary hypertension: chronic thromboembolic pulmonary hypertension (CTEPH) and pulm…
FDA Approves Vyvgart Hytrulo (efgartigimod alfa/hyaluronidase) for CIDP and gMG
FDA approves new shot for two nerve and muscle conditions.
The FDA approved Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase) for adult patients with chronic inflammatory demyelinating polyneurop…
The FDA approved Vyvgart Hytrulo, a weekly shot, for adults with generalized myasthenia gravis (gMG) or chronic inflammatory demyelinating p…
FDA Approves Vyvgart (efgartigimod alfa) for Generalized Myasthenia Gravis
FDA approves new drug Vyvgart for a form of myasthenia gravis.
The FDA approved Vyvgart (efgartigimod alfa) for generalized myasthenia gravis in adult patients who are anti-AChR antibody positive. Approv…
The FDA approved Vyvgart (efgartigimod alfa) for adults with generalized myasthenia gravis who test positive for a certain antibody. This ne…
FDA Approves Ocrevus (ocrelizumab) for Relapsing and Primary Progressive Multiple Sclerosis
FDA approves Ocrevus, a new drug for two forms of multiple sclerosis.
FDA approved Ocrevus (ocrelizumab) for relapsing forms of MS (including clinically isolated syndrome, relapsing-remitting disease, and activ…
The FDA approved Ocrevus (ocrelizumab) to treat relapsing forms of MS and primary progressive MS (PPMS) in adults. It is the first drug appr…
FDA Approves Vabrinty (leuprolide acetate) for Advanced Prostate Cancer
FDA approves new drug Vabrinty for advanced prostate cancer.
The FDA approved Vabrinty (leuprolide acetate) for the treatment of advanced prostate cancer. It is a GnRH agonist administered subcutaneous…
The FDA approved Vabrinty (leuprolide acetate) to treat advanced prostate cancer. It is a hormone therapy that lowers testosterone levels. T…
FDA Approves Talvey (talquetamab) for Relapsed/Refractory Multiple Myeloma
FDA approves new multiple myeloma drug Talvey for certain patients.
The FDA has approved Talvey (talquetamab) for adult patients with relapsed or refractory multiple myeloma who have received at least four pr…
The FDA approved Talvey (talquetamab) for adults with multiple myeloma who have tried at least four other treatments. It is for patients who…
FDA Approves Tecvayli (teclistamab) for Relapsed or Refractory Multiple Myeloma
FDA approves new drug Tecvayli for advanced multiple myeloma.
The FDA approved Tecvayli (teclistamab) for relapsed or refractory multiple myeloma in combination with daratumumab and hyaluronidase-fihj a…
The FDA approved Tecvayli (teclistamab) for adults with multiple myeloma that has come back or not responded to treatment. It is used alone …
FDA Approves Zoladex (goserelin) for Multiple Indications Including Prostate Cancer and Endometriosis
FDA approves Zoladex for prostate cancer, endometriosis, and breast cancer.
The FDA approved Zoladex (goserelin) for use in combination with flutamide for locally confined prostate cancer, palliative treatment of adv…
The FDA has approved Zoladex (goserelin) to treat prostate cancer, endometriosis, and advanced breast cancer. It is given as a shot every 28…
FDA Approves VABRINTY (leuprolide acetate) for Advanced Prostate Cancer
FDA approves Vabrinty for advanced prostate cancer with flexible dosing.
The FDA approved VABRINTY (leuprolide acetate) for the treatment of advanced prostate cancer. It is a GnRH agonist administered subcutaneous…
The FDA approved Vabrinty (leuprolide acetate) for advanced prostate cancer. It is a hormone therapy given as a shot every 1 to 6 months. Th…
FDA Approves Zoladex (goserelin) for Locally Confined and Advanced Prostate Cancer
FDA approves Zoladex for prostate cancer treatment.
FDA approved Zoladex (goserelin) for use in combination with flutamide for locally confined stage T2b-T4 prostate cancer and as palliative t…
The FDA approved Zoladex (goserelin) for two uses in prostate cancer: with radiation for early stage cancer and as palliative care for advan…
FDA Approves Levothyroxine Sodium Tablets for Hypothyroidism and TSH Suppression
FDA approves new thyroid hormone drug for hypothyroidism and thyroid cancer.
The FDA approved levothyroxine sodium tablets for replacement therapy in primary, secondary, and tertiary hypothyroidism, and as an adjunct …
The FDA has approved levothyroxine sodium tablets to treat hypothyroidism and as part of therapy for certain thyroid cancers. This synthetic…
FDA Approves Lazcluze (lazertinib) with Amivantamab for EGFR-Mutant NSCLC
FDA approves new lung cancer pill Lazcluze for certain patients.
FDA approved Lazcluze (lazertinib) in combination with amivantamab for first-line treatment of adults with locally advanced or metastatic NS…
The FDA approved Lazcluze (lazertinib) with another drug for adults with a common type of advanced lung cancer. This new oral treatment is f…
FDA Approves Perseris (risperidone) for Treatment of Schizophrenia in Adults
FDA approves new monthly shot Perseris for schizophrenia in adults.
The FDA approved Perseris, a long-acting injectable atypical antipsychotic, for the treatment of schizophrenia in adults. It is administered…
The FDA approved Perseris, a once-monthly injectable form of risperidone, for treating schizophrenia in adults. This new option may help pat…
FDA Approves Children's Advil (ibuprofen) for Fever and Minor Aches in Children
FDA approves Children's Advil for fever and pain in kids ages 2 and up.
The FDA approved Children's Advil (ibuprofen) for temporary reduction of fever and relief of minor aches and pains due to common cold, flu, …
The FDA approved Children's Advil (ibuprofen) for over-the-counter use in children as young as 2 years to reduce fever and relieve minor ach…
FDA Approves Children's Advil (ibuprofen) for Fever and Minor Aches in Children
FDA approves Children's Advil for fever and pain relief in kids.
The FDA approved Children's Advil (ibuprofen) oral suspension for temporary fever reduction and relief of minor aches and pains due to commo…
The FDA has approved Children's Advil (ibuprofen) for over-the-counter use in children to reduce fever and relieve minor aches and pains. It…
FDA Approves Precedex (dexmedetomidine) for Pediatric Procedural Sedation
FDA approves Precedex for sedation in children during procedures.
The FDA approved Precedex (dexmedetomidine) for sedation of non-intubated pediatric patients aged 1 month to less than 18 years during non-i…
The FDA approved Precedex (dexmedetomidine) to sedate children aged 1 month to 17 years during non-invasive procedures. It provides sedation…
FDA Approves Dexmedetomidine Hydrochloride for ICU and Procedural Sedation in Adults
FDA approves new sedative for hospital and procedure sedation.
FDA approved dexmedetomidine hydrochloride for sedation of initially intubated and mechanically ventilated adult patients in the ICU, and fo…
The FDA approved dexmedetomidine hydrochloride for sedation in intensive care and during procedures. It helps keep patients calm without slo…
FDA Approves Pavblu (aflibercept) for Neovascular AMD, RVO, DME, and DR
FDA approves Pavblu to treat several eye conditions that cause vision loss.
The FDA approved Pavblu (aflibercept) for neovascular AMD, macular edema following RVO, DME, and DR. It is a VEGF inhibitor administered by …
The FDA approved Pavblu (aflibercept) for wet age-related macular degeneration, macular edema, diabetic macular edema, and diabetic retinopa…
FDA Approves Ngenla (somatrogon-ghla) for Pediatric Growth Hormone Deficiency
FDA approves once-weekly growth hormone drug Ngenla for children
FDA approved Ngenla (somatrogon-ghla) for treatment of pediatric patients aged 3 years and older with growth failure due to inadequate secre…
The FDA approved Ngenla (somatrogon-ghla), a once-weekly injection for children 3 and older with growth failure due to low growth hormone. I…
FDA Approves Crestor (rosuvastatin) for Cardiovascular Risk Reduction in Adults
FDA approves Crestor to prevent heart attacks and strokes in certain adults.
FDA approved Crestor (rosuvastatin) to reduce risk of major adverse cardiovascular events in adults without established coronary heart disea…
The FDA approved Crestor (rosuvastatin) to reduce the risk of heart attack, stroke, and related events in adults without heart disease but w…
FDA Approves Hadlima (adalimumab) for Multiple Inflammatory Indications
FDA approves Hadlima, a new biosimilar for several inflammatory diseases.
The FDA approved Hadlima (adalimumab) for several inflammatory conditions including rheumatoid arthritis, juvenile idiopathic arthritis, pso…
The FDA approved Hadlima (adalimumab) for treating conditions like rheumatoid arthritis, psoriasis, and Crohn's disease. It is a biosimilar,…
FDA Approves Rexulti (brexpiprazole) for Agitation in Alzheimer's Dementia
FDA approves Rexulti to treat agitation in Alzheimer's patients
FDA approved Rexulti (brexpiprazole) for treatment of agitation associated with dementia due to Alzheimer's disease. It is not indicated for…
The FDA approved Rexulti (brexpiprazole) to treat agitation in people with Alzheimer's disease. This is a new option for managing this chall…
FDA Approves Xpovio (selinexor) for Multiple Myeloma and DLBCL
FDA approves new drug Xpovio for certain blood cancers.
The FDA approved Xpovio (selinexor) for multiple myeloma in combination with bortezomib and dexamethasone after at least one prior therapy, …
The FDA approved Xpovio (selinexor) for multiple myeloma and a type of lymphoma called DLBCL. It offers a new option for patients who have t…
FDA Approves Auvelity (dextromethorphan/bupropion) for Major Depressive Disorder and Agitation in Alzheimer's
FDA approves new drug Auvelity for depression and Alzheimer's agitation.
The FDA approved Auvelity (dextromethorphan/bupropion) for major depressive disorder (MDD) and agitation associated with dementia due to Alz…
The FDA approved Auvelity for major depressive disorder and agitation in Alzheimer's disease. It combines two medicines into one pill. This …
FDA Approves Nuplazid (pimavanserin) for Parkinson's Disease Psychosis
FDA approves first drug for hallucinations in Parkinson's disease
FDA approved Nuplazid (pimavanserin) for hallucinations and delusions associated with Parkinson's disease psychosis. In a 6-week trial, Nupl…
The FDA approved Nuplazid (pimavanserin) to treat hallucinations and delusions in people with Parkinson's disease psychosis. It is the first…
FDA Approves Enhertu (fam-trastuzumab deruxtecan-nxki) for Multiple HER2-Positive and HER2-Low Cancers
FDA approves Enhertu for several types of HER2 positive cancers.
FDA approved Enhertu for several indications including HER2-positive metastatic breast cancer, HER2-low and HER2-ultralow breast cancer, HER…
The FDA has approved Enhertu for multiple cancers, including breast, lung, stomach, and other solid tumors that have a specific protein call…
FDA Approves Nuplazid (pimavanserin) for Parkinson's Disease Psychosis
FDA approves first drug for hallucinations in Parkinson's disease
The FDA approved Nuplazid (pimavanserin) for hallucinations and delusions associated with Parkinson's disease psychosis. Approval was based …
The FDA approved Nuplazid (pimavanserin) to treat hallucinations and delusions in people with Parkinson's disease psychosis. It is the first…
FDA Approves Revlimid (lenalidomide) for Multiple Myeloma and Other Indications
FDA approves Revlimid for several blood cancers and related conditions.
FDA approved Revlimid (lenalidomide) for multiple myeloma (in combination with dexamethasone and as maintenance after auto-HSCT), transfusio…
The FDA approved Revlimid (lenalidomide) for multiple myeloma, certain myelodysplastic syndromes, mantle cell lymphoma, and other lymphomas.…
FDA Approves Breztri Aerosphere (budesonide/glycopyrrolate/formoterol) for COPD Maintenance
FDA approves new triple-combination inhaler Breztri Aerosphere for COPD.
The FDA approved Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) for maintenance treatment of COPD. It is a triple-combin…
The FDA approved Breztri Aerosphere, a triple-combination inhaler, for the long-term treatment of chronic obstructive pulmonary disease (COP…
FDA Approves Pomalyst (pomalidomide) for Multiple Myeloma and Kaposi Sarcoma
FDA approves new drug Pomalyst for multiple myeloma and Kaposi sarcoma.
The FDA approved Pomalyst (pomalidomide) for multiple myeloma in combination with dexamethasone after at least two prior therapies, and for …
The FDA approved Pomalyst (pomalidomide) for two conditions: multiple myeloma and Kaposi sarcoma. It offers a new option for patients who ha…
FDA Approves Epysqli (eculizumab-sbja) for PNH, aHUS, and gMG
FDA approves new drug Epysqli for three rare blood and nerve conditions.
The FDA approved Epysqli (eculizumab-sbja) for paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and gen…
The FDA approved Epysqli (eculizumab-sbja) for paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and generalized myas…
FDA Approves Caplyta (lumateperone) for Schizophrenia in Adults
FDA approves Caplyta to treat schizophrenia in adults
FDA approved Caplyta (lumateperone) for treatment of schizophrenia in adults.
The FDA approved Caplyta (lumateperone) for treating schizophrenia in adults.
FDA Approves IC-GREEN (indocyanine green) for Fluorescence Imaging in Multiple Indications
FDA approves IC-GREEN dye to help surgeons see blood flow and tissues during operations
The FDA approved IC-GREEN (indocyanine green) for fluorescence imaging of vessels, blood flow, tissue perfusion, extrahepatic biliary ducts,…
The FDA approved IC-GREEN (indocyanine green) to help surgeons see blood vessels, bile ducts, and lymph nodes during certain surgeries.
FDA Approves Mydayis (mixed salts of a single-entity amphetamine) for ADHD in Patients 13 and Older
FDA approves new ADHD drug Mydayis for patients 13 and older
FDA approved Mydayis, a CNS stimulant, for ADHD in patients 13 years and older.
The FDA approved Mydayis, a once-daily stimulant for ADHD in people 13 and older. It can last up to 16 hours, which may cause insomnia. This…
FDA Approves Vyvanse (lisdexamfetamine) for Binge Eating Disorder in Adults
FDA approves Vyvanse to treat binge eating disorder in adults
The FDA approved Vyvanse (lisdexamfetamine) for moderate to severe binge eating disorder (BED) in adults.
The FDA has approved Vyvanse (lisdexamfetamine) for moderate to severe binge eating disorder in adults.
FDA Approves Metronidazole Injection for Anaerobic Infections and Prophylaxis
FDA approves new antibiotic for serious anaerobic bacterial infections
The FDA approved Metronidazole Injection for treatment of serious anaerobic infections and for prophylaxis in elective colorectal surgery.
The FDA approved Metronidazole Injection USP for serious infections caused by anaerobic bacteria.
FDA Approves Crysvita (burosumab) for X-Linked Hypophosphatemia and Tumor-Induced Osteomalacia
FDA approves new drug Crysvita for rare bone diseases in children and adults
FDA approved Crysvita (burosumab) for X-linked hypophosphatemia (XLH) in patients 6 months and older and for tumor-induced osteomalacia (TIO…
The FDA approved Crysvita (burosumab) for X-linked hypophosphatemia (XLH) and tumor-induced osteomalacia (TIO).
FDA Approves Vyvanse (lisdexamfetamine) for Binge Eating Disorder
FDA approves Vyvanse to treat binge eating disorder in adults
FDA approved Vyvanse (lisdexamfetamine) for moderate to severe binge eating disorder (BED) in adults.
The FDA approved Vyvanse for moderate to severe binge eating disorder in adults. It is a stimulant already used for ADHD. This gives patient…
FDA Approves Perjeta (pertuzumab) for HER2-Positive Breast Cancer
FDA approves new drug Perjeta for HER2-positive breast cancer
The FDA approved Perjeta (pertuzumab) for use in combination with trastuzumab and chemotherapy for HER2-positive metastatic breast cancer an…
The FDA approved Perjeta (pertuzumab) for HER2-positive breast cancer.
FDA Approves Zurzuvae (zuranolone) for Postpartum Depression in Adults
FDA approves new pill for postpartum depression, offering faster relief
FDA approved Zurzuvae (zuranolone) for postpartum depression (PPD) in adults.
The FDA approved Zurzuvae (zuranolone), a daily pill for postpartum depression. It works quickly over 14 days. This gives new mothers an ora…
FDA Approves Tzield (teplizumab) to Delay Onset of Stage 3 Type 1 Diabetes
FDA approves Tzield to delay type 1 diabetes in high-risk patients
The FDA approved Tzield (teplizumab) to delay the onset of Stage 3 type 1 diabetes in patients aged 1 year and older with Stage 2 disease.
The FDA approved Tzield (teplizumab) to delay the onset of stage 3 type 1 diabetes in people aged 1 and older with stage 2 disease.
FDA Approves Ontruzant (trastuzumab-dttb) for HER2-Overexpressing Breast and Gastric Cancers
FDA approves new cancer drug called Ontruzant for certain breast and stomach cancers
Ontruzant (trastuzumab-dttb) is approved for HER2-overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarc…
The FDA has approved a new drug called Ontruzant for treating certain breast and stomach cancers.
FDA Approves Cosentyx (secukinumab) for moderate to severe plaque psoriasis in adults and pediatric patients 6 years and older
The FDA has approved a new drug called Cosentyx for treating a serious skin condition
The FDA approved Cosentyx (secukinumab) for moderate to severe plaque psoriasis in adults and pediatric patients 6 years and older who are c…
The FDA approved Cosentyx for moderate to severe plaque psoriasis in adults and children 6 and older.
FDA Approves Cosentyx (secukinumab) for Moderate to Severe Hidradenitis Suppurativa in Adults and Pediatric Patients
The FDA approved a new use for the drug Cosentyx to treat a painful skin condition
The FDA has approved Cosentyx for moderate to severe hidradenitis suppurativa in adults and pediatric patients 12 years and older.
The FDA has approved Cosentyx for treating moderate to severe hidradenitis suppurativa, a chronic skin condition that causes painful lumps.
FDA Approves DATSCAN (ioflupane I-123) for Striatal Dopamine Transporter Visualization in Suspected Parkinsonian Syndromes or Dementia with Lewy Bodies
FDA approves new brain imaging drug to help doctors diagnose Parkinson's and similar conditions
DATSCAN is approved as an adjunct diagnostic for striatal dopamine transporter visualization using SPECT brain imaging in adult patients wit…
FDA approves new brain imaging drug to help doctors diagnose Parkinson's and similar conditions.
FDA Approves Stelara (ustekinumab) for moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis
The FDA approved a drug called Stelara to treat several inflammatory conditions in adults and children
The FDA approved ustekinumab for adult and pediatric patients 6 years and older with moderate to severe plaque psoriasis and active psoriati…
FDA approved Stelara to treat moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis in adults an…
FDA Approves Wainua (autoinjector) for Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis in Adults
FDA approves new monthly injection called Wainua for a rare nerve disease in adults
The FDA approved Wainua, a transthyretin-directed antisense oligonucleotide, for treating polyneuropathy of hereditary transthyretin-mediate…
FDA approves new monthly injection Wainua to treat nerve damage in adults with a rare inherited disease called hereditary transthyretin-medi…
FDA Approves Stelara (ustekinumab) for moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis
The FDA has approved a new drug called Stelara for several inflammatory conditions
The FDA approved ustekinumab for adult and pediatric patients 6 years and older with moderate to severe plaque psoriasis and active psoriati…
The FDA has approved Stelara to treat moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis in a…
FDA Approves Itovebi (Itovebi) for Endocrine-Resistant, PIK3CA-Mutated, HR-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
FDA approves new breast cancer drug Itovebi for a specific type of advanced cancer
The FDA approved Itovebi in combination with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, HR-positive, H…
A new oral drug, Itovebi, is now FDA-approved for advanced breast cancer with a specific genetic mutation, offering another option when horm…
FDA Approves Dupixent (dupilumab) for Allergic Fungal Rhinosinusitis in Patients with History of Sino-Nasal Surgery
FDA approves Dupixent for treating allergic fungal sinus infections in patients who have had sinus surgery
Dupixent (dupilumab) has been approved for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosi…
FDA approves Dupixent for allergic fungal sinus infections in adults and children aged 6 and older who have had sinus surgery.
FDA Approves Spravato (esketamine) for Treatment-Resistant Depression and Depressive Symptoms with Acute Suicidal Ideation in Adults
The FDA approved a new nasal spray called Spravato for severe depression
The FDA approved Spravato (esketamine) for treatment-resistant depression in adults as monotherapy or with an oral antidepressant, and for d…
FDA approved a new nasal spray for severe depression when other treatments fail or when patients face acute suicidal thoughts.
FDA Approves Abreva () for cold sores/fever blisters on the face or lips to shorten healing time and duration of symptoms
The FDA has approved a new non-prescription drug called Abreva for treating cold sores
The FDA approved Abreva for treating cold sores/fever blisters on the face or lips to shorten healing time and duration of symptoms such as …
FDA approves new over-the-counter drug Abreva to shorten cold sore healing time and ease painful symptoms like tingling and itching.
FDA Approves Rytelo (telomerase inhibitor oligonucleotide) for transfusion-dependent anemia in low- to intermediate-1 risk MDS
FDA approves new drug called Rytelo for certain blood disorder patients who need frequent transfusions
Rytelo is approved for adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) who have transfusion-dependent anemia…
FDA approves Rytelo to help adults with low-risk blood disorders who need frequent transfusions after other treatments fail.
FDA Approves Danziten (nilotinib) for Adult Patients with Newly Diagnosed or Resistant/Intolerant Ph+ CML
The FDA approved a new drug called Danziten for a type of blood cancer called CML
Danziten (nilotinib) is approved for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML)…
The FDA approved Danziten to treat newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia or cases resistant to prior ima…
FDA Approves Vanflyta (quizartinib) for Newly Diagnosed FLT3-ITD-Positive AML in Adults
FDA approves new drug called Vanflyta for a specific type of blood cancer in adults
Vanflyta is approved in combination with induction and consolidation chemotherapy, and as maintenance monotherapy, for adult patients with n…
FDA approves Vanflyta to treat acute myeloid leukemia in adults with a specific genetic change that makes the cancer harder to manage.
Prochlorperazine Labeling: Indicated for Severe Nausea/Vomiting and Schizophrenia
The FDA approved a new injection to treat severe nausea and schizophrenia when pills cannot be taken
FDA labeling for prochlorperazine lists two approved indications: control of severe nausea and vomiting and treatment of schizophrenia.
A new FDA-approved injection now treats severe nausea and schizophrenia when patients cannot take pills by mouth.
FDA Approves Concerta (methylphenidate) for ADHD in Patients Aged 6 to 65 Years
The FDA approved a new once-daily ADHD medication called Concerta for people ages 6 to 65
Concerta (methylphenidate) is approved for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years.
The FDA approved Concerta, a once-daily ADHD medication, for people ages 6 to 65 to help manage symptoms throughout the day with a single do…
FDA Approves Valproic Acid Capsules (valproic acid) for monotherapy and adjunctive therapy of complex partial seizures and absence seizures
The FDA has approved a new epilepsy drug called Valproic Acid Capsules for treating seizures
Valproic Acid Capsules were approved for monotherapy and adjunctive therapy of complex partial seizures, and sole and adjunctive therapy of …
The FDA approved Valproic Acid Capsules to treat complex partial and absence seizures in people aged 10 and older.
FDA Approves Rezenopy (naloxone) for Emergency Treatment of Opioid Overdose
FDA approves new nasal spray called Rezenopy for emergency treatment of opioid overdose
The FDA approved Rezenopy nasal spray for emergency treatment of known or suspected opioid overdose in adult and pediatric patients.
FDA approves new nasal spray Rezenopy to quickly reverse opioid overdose in adults and children when someone shows slow breathing or is unre…
FDA Approves Cosopt Pf (dorzolamide hydrochloride-timolol maleate ophthalmic solution) for reduction of elevated intraocular pressure in open-angle glaucoma or ocular hypertension
The FDA approved a new preservative-free eye drop called Cosopt Pf for treating high eye pressure
FDA approved Cosopt Pf, a preservative-free ophthalmic solution of dorzolamide hydrochloride and timolol maleate, for reducing elevated intr…
FDA approves new preservative-free eye drop for high eye pressure in patients who don't respond well to beta-blockers.
FDA Approves Onureg (azacitidine) for Continued Treatment of Adult AML Patients in First Remission After Intensive Chemotherapy
The FDA approved a new oral drug called Onureg for certain leukemia patients in remission
FDA approved Onureg for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission or complete …
FDA approved oral drug Onureg for leukemia patients in remission who cannot complete intensive curative therapy.
FDA Approves Lamotrigine Tablets (lamotrigine) for Epilepsy and Bipolar Disorder Maintenance
The FDA has approved a drug called lamotrigine for epilepsy and bipolar disorder treatment
Lamotrigine tablets were approved as adjunctive therapy for partial-onset seizures, PGTC seizures, and Lennox-Gastaut syndrome in patients a…
The FDA has approved lamotrigine to help control seizures in children as young as two and maintain mood stability for adults with bipolar di…
FDA Approves Vabysmo (faricimab) for Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema, and Macular Edema Following Retinal Vein Occlusion
The FDA approved a new eye medicine called Vabysmo for several vision conditions
Vabysmo (faricimab) is approved for neovascular age-related macular degeneration, diabetic macular edema, and macular edema following retina…
FDA approved Vabysmo to treat wet age-related macular degeneration, diabetic macular edema, and swelling after retinal vein occlusion.
FDA Approves Fosfomycin Tromethamine (fosfomycin tromethamine) for Uncomplicated Urinary Tract Infections in Women
FDA approves new single-dose antibiotic for treating bladder infections in women
Fosfomycin tromethamine granules for oral solution was approved for uncomplicated urinary tract infections (acute cystitis) in women due to …
FDA approves a new single-dose antibiotic for women with bladder infections, offering a convenient one-time treatment option for common urin…
FDA Approves Beyfortus (nirsevimab-alip) for Prevention of RSV Lower Respiratory Tract Disease in Neonates and Infants
FDA approves new drug called Beyfortus to help protect babies and young children from serious RSV illness
Beyfortus is approved for preventing RSV lower respiratory tract disease in neonates and infants during their first RSV season, and in child…
FDA approves Beyfortus to prevent serious RSV illness in newborns and infants during their first season and children up to 2 years old in th…
FDA Approves Skyclarys for Friedreich's Ataxia in Adults and Adolescents Aged 16 Years and Older
The FDA has approved a new drug called Skyclarys for a rare nerve disorder
Skyclarys is approved for treating Friedreich's ataxia in adults and adolescents aged 16 years and older.
The FDA has approved Skyclarys to treat Friedreich's ataxia, a rare nerve disorder that causes movement problems in adults and teens aged 16…
FDA Approves Ondansetron Injection, USP (ondansetron hydrochloride) for prevention of nausea and vomiting associated with emetogenic cancer chemotherapy and postoperative nausea/vomiting
FDA approves a new injection to help prevent nausea and vomiting from cancer treatment and surgery
FDA approved ondansetron injection for prevention of nausea and vomiting associated with emetogenic cancer chemotherapy and postoperative na…
FDA approves new injection to prevent nausea and vomiting from cancer treatment and surgery for children as young as one month old.
FDA Approves Tyvaso (treprostinil) for Pulmonary Arterial Hypertension and Pulmonary Hypertension Associated with Interstitial Lung Disease
FDA approves new inhaled drug called Tyvaso for two serious lung conditions
The FDA approved Tyvaso (treprostinil) for pulmonary arterial hypertension (PAH; WHO Group 1) and pulmonary hypertension associated with int…
FDA approves new inhaled drug Tyvaso to help adults with serious lung conditions improve their ability to exercise and do daily activities.
FDA Approves Dapagliflozin Tablets (dapagliflozin) for Heart Failure Risk Reduction and Glycemic Control in Type 2 Diabetes
FDA approves a diabetes drug that also helps protect the heart in certain adults
The FDA has approved dapagliflozin tablets to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and establ…
A new diabetes tablet now helps control blood sugar while also lowering the risk of heart failure hospitalization for adults with heart dise…
FDA Approves Dapagliflozin Tablets (dapagliflozin) for Type 2 Diabetes and Heart Failure Risk Reduction
FDA approves a new pill for type 2 diabetes that also helps protect the heart
The FDA has approved dapagliflozin tablets for two indications in adults with type 2 diabetes mellitus: to improve glycemic control and to r…
A new FDA-approved pill for type 2 diabetes now helps lower blood sugar while also reducing the risk of hospitalization for heart failure.
FDA Approves Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets for Type 2 Diabetes and Related Risks
FDA approves a new once-daily pill for type 2 diabetes that may also help protect the heart and kidneys
The FDA has approved dapagliflozin and metformin hydrochloride extended-release tablets as an adjunct to diet and exercise to improve glycem…
A new once-daily pill for type 2 diabetes may protect the heart and kidneys from serious problems like heart attacks and worsening kidney di…
FDA Approves Cefepime for Injection and Dextrose Injection (cefepime) for Moderate to Severe Pneumonia and Other Infections
The FDA approved a new ready-to-use version of an antibiotic called cefepime for serious infections
The FDA approved cefepime in a dextrose injection formulation for intravenous treatment of moderate to severe pneumonia, febrile neutropenia…
The FDA approved a ready-to-use antibiotic for serious infections like pneumonia and urinary tract infections in hospitalized patients.
FDA Approves Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for PSMA-positive metastatic castration-resistant prostate cancer
FDA approves a new treatment for advanced prostate cancer called Pluvicto
The FDA has approved Pluvicto, a radioligand therapeutic agent, for the treatment of adult patients with PSMA-positive metastatic castration…
FDA approves Pluvicto, a targeted radiation therapy for advanced prostate cancer that has spread and stopped responding to standard hormone …
FDA Approves Levetiracetam for Partial-Onset, Myoclonic, and Primary Generalized Tonic-Clonic Seizures
FDA approves a seizure medicine called levetiracetam for children and adults
Levetiracetam is approved for the treatment of partial-onset seizures in patients 1 month and older, and as adjunctive therapy for myoclonic…
The FDA now approves levetiracetam for children as young as one month and adults to treat specific seizure types.
FDA Approves Ingrezza Sprinkle (valbenazine) for Tardive Dyskinesia and Chorea Associated with Huntington’s Disease
FDA approves a new sprinkle version of Ingrezza for two movement disorders
The FDA has approved Ingrezza Sprinkle, a VMAT2 inhibitor, for the treatment of adults with tardive dyskinesia and chorea associated with Hu…
FDA approves sprinkle form of Ingrezza to treat involuntary movements in adults with tardive dyskinesia or Huntington's disease chorea.
FDA Approves Ondansetron Injection, USP (ondansetron hydrochloride) for Prevention of Chemotherapy-Induced and Postoperative Nausea/Vomiting
FDA approves a new preservative-free injection to prevent nausea and vomiting from chemotherapy and surgery
FDA approved ondansetron injection for prevention of nausea/vomiting associated with emetogenic cancer chemotherapy and postoperative nausea…
FDA approves a new preservative-free injection to prevent nausea and vomiting from chemotherapy and surgery.
FDA Approves Gabapentin Capsules (gabapentin) for Postherpetic Neuralgia and Partial Onset Seizures
FDA approves a new generic version of the drug gabapentin for nerve pain and seizures
The FDA has approved Gabapentin Capsules, USP for the management of postherpetic neuralgia in adults and as adjunctive therapy for partial o…
FDA approves a new generic gabapentin capsule for nerve pain and seizures, offering patients another low-cost treatment option alongside exi…
FDA Approves Dapagliflozin Tablets (dapagliflozin) to Reduce Heart Failure Hospitalization Risk and Improve Glycemic Control in Adults with Type 2 Diabetes
FDA approves a diabetes drug that also helps protect the heart in certain adults
The FDA has approved dapagliflozin tablets to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus a…
A new diabetes drug is approved to lower blood sugar and cut the risk of heart failure hospitalization in adults with type 2 diabetes and he…
FDA Approves Dapagliflozin for Heart Failure Risk Reduction and Glycemic Control in Type 2 Diabetes
FDA approves a diabetes drug that also helps protect the heart from failure
The FDA has approved dapagliflozin to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and established ca…
FDA approves a diabetes pill that lowers blood sugar and reduces heart failure hospitalization for adults with type 2 diabetes and heart ris…
FDA Approves Dapagliflozin for Reducing Heart Failure Hospitalization Risk and Improving Glycemic Control in Adults with Type 2 Diabetes
FDA approves a diabetes drug that also helps protect the heart
The FDA has approved dapagliflozin to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and estab…
A new diabetes drug now helps lower blood sugar while also reducing the risk of heart failure hospitalization for adults with heart disease …
FDA Approves Dapagliflozin Tablets (dapagliflozin) for Type 2 Diabetes and Heart Failure Risk Reduction
FDA approves a new diabetes pill that also helps protect the heart
The FDA has approved dapagliflozin tablets for two indications: to improve glycemic control in adults with type 2 diabetes mellitus, and to …
A new daily diabetes pill now approved by the FDA helps lower blood sugar and reduces the risk of heart failure hospitalization for adults w…
FDA Approves Dapagliflozin Tablets (dapagliflozin) for Heart Failure Risk Reduction and Glycemic Control in Type 2 Diabetes
FDA approves a diabetes pill that also helps protect the heart from failure
The FDA has approved dapagliflozin tablets to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and establ…
A new diabetes pill approved by the FDA also lowers the risk of hospitalization for heart failure in adults with type 2 diabetes.
FDA Approves Dapagliflozin Tablets (dapagliflozin) for Heart Failure Risk Reduction and Glycemic Control in Type 2 Diabetes
FDA approves a diabetes drug that also helps lower the risk of heart failure
The FDA has approved dapagliflozin tablets to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and establ…
A new diabetes pill now helps lower blood sugar and reduces the risk of hospitalization for heart failure in adults with type 2 diabetes.
FDA Approves Keytruda (pembrolizumab) for Treatment of Unresectable or Metastatic Melanoma
FDA approves new drug Keytruda for advanced skin cancer
The FDA has approved Keytruda, a PD-1-blocking antibody, for the treatment of patients with unresectable or metastatic melanoma.
FDA approves Keytruda to treat advanced skin cancer that cannot be removed by surgery or has spread to other parts of the body.
FDA Approves Dapagliflozin Tablets (dapagliflozin) to Reduce Heart Failure Hospitalization Risk in Adults with Type 2 Diabetes
FDA approves a diabetes drug that also helps protect the heart
The FDA has approved dapagliflozin tablets to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus a…
A new diabetes drug now protects the heart by lowering hospitalization risks for adults with type 2 diabetes and existing heart disease.
FDA Approves Valproic Acid Oral Solution (valproic acid) for Monotherapy and Adjunctive Therapy of Complex Partial and Absence Seizures
The FDA has approved a liquid form of an existing epilepsy and migraine prevention medicine
The FDA has approved valproic acid oral solution for monotherapy and adjunctive therapy of complex partial seizures, and as sole and adjunct…
The FDA approved a liquid version of valproic acid, an established epilepsy and migraine medicine, offering an easier swallowing option for …
FDA Approves Valproic Acid Oral Solution (valproic acid) for Monotherapy and Adjunctive Therapy of Complex Partial and Absence Seizures
FDA approves a liquid form of an existing epilepsy medicine called valproic acid
The FDA has approved valproic acid oral solution for monotherapy and adjunctive therapy of complex partial seizures, and as sole and adjunct…
FDA approves liquid valproic acid for epilepsy patients 10 and older who struggle to swallow pills or need flexible dosing.
FDA Approves Valproic Acid Oral Solution (valproic acid) for Complex Partial and Absence Seizures
The FDA has approved a liquid form of an older seizure medicine called valproic acid
Valproic acid oral solution is approved as monotherapy and adjunctive therapy for complex partial seizures and for simple and complex absenc…
The FDA approved a liquid version of valproic acid to help adults and children over 10 manage complex partial and absence seizures when pill…
FDA Approves Eylea HD (aflibercept) for nAMD, DME, Diabetic Retinopathy, and Macular Edema Following RVO
FDA approves a new, higher-dose version of the eye medicine Eylea
The FDA has approved Eylea HD, a VEGF inhibitor, for the treatment of neovascular age-related macular degeneration, diabetic macular edema, …
FDA approves higher-dose Eylea to treat four eye conditions that damage the retina and threaten vision, potentially reducing how often patie…
FDA Approves Nintedanib Capsules (nintedanib esylate) for Idiopathic Pulmonary Fibrosis and Progressive Fibrosing ILDs
FDA approves a new drug to treat two types of progressive, scarring lung diseases
The FDA has approved nintedanib capsules for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and for adults with chronic fi…
FDA approves new drug to treat two types of progressive, scarring lung diseases that make lungs stiff and hard to breathe.
FDA Approves Nintedanib Capsules (nintedanib esylate) for Idiopathic Pulmonary Fibrosis and Progressive Fibrosing ILDs
FDA approves a new drug to treat two serious, scarring lung diseases in adults
The FDA has approved nintedanib capsules for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and for adults with chronic fi…
FDA approves new drug nintedanib to treat two serious, scarring lung diseases in adults with progressive conditions.
FDA Approves FOUNDAYO (orforglipron) for chronic weight management in adults with obesity or overweight with comorbidities
The FDA has approved a new daily pill called FOUNDAYO to help adults manage their weight
The FDA has approved FOUNDAYO (orforglipron), an oral GLP-1 receptor agonist, for chronic weight management in adults with obesity or overwe…
FDA approves new daily pill FOUNDAYO for adults to manage weight alongside diet and exercise.
FDA Approves Kesimpta (ofatumumab) for Relapsing Forms of Multiple Sclerosis in Adults
The FDA approved a new monthly self-injection drug for multiple sclerosis
The FDA has approved Kesimpta, a CD20-directed cytolytic antibody, for the treatment of relapsing forms of multiple sclerosis in adults.
The FDA approved Kesimpta, a new monthly self-injection for adults with relapsing forms of multiple sclerosis.
FDA Approves Vafseo (vadadustat) for Anemia Due to Chronic Kidney Disease in Adults on Dialysis
FDA approves a new oral pill for anemia in adults with chronic kidney disease on dialysis
The FDA has approved Vafseo (vadadustat) for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysi…
FDA approves a new oral pill for anemia in adults with chronic kidney disease on dialysis, offering a non-transfusion option for those treat…
FDA Approves Zynyz (retifanlimab-dlwr) for Metastatic Anal Canal Cancer and Merkel Cell Carcinoma
FDA approves new drug Zynyz for two rare and aggressive types of cancer
The FDA has approved Zynyz, a PD-1 blocking antibody, for two indications: first-line treatment of inoperable locally recurrent or metastati…
FDA approves new drug Zynyz to treat two rare and aggressive cancers: advanced anal cancer and Merkel cell carcinoma.
FDA Approves Lamotrigine for Adjunctive Therapy in Epilepsy and Maintenance in Bipolar I Disorder
FDA approves lamotrigine, a medicine for epilepsy and bipolar disorder
Lamotrigine is approved for adjunctive therapy of partial-onset seizures, PGTC seizures, and seizures of Lennox-Gastaut syndrome in patients…
The FDA officially approves lamotrigine for epilepsy and bipolar disorder, confirming a long-used treatment option for adults and children a…
FDA Approves Bupropion Hydrochloride Extended-Release Tablets (SR) (bupropion) for Major Depressive Disorder
FDA approves a new, longer-acting version of the antidepressant bupropion
The FDA has approved Bupropion Hydrochloride Extended-Release Tablets (SR) for the treatment of major depressive disorder (MDD).
A new extended-release antidepressant now helps adults manage depression for up to 44 weeks following initial treatment.
FDA Approves Byooviz (ranibizumab) for Neovascular AMD, Macular Edema Following RVO, and Myopic CNV
FDA approves a new eye medicine called Byooviz for three conditions that can cause vision loss
The FDA has approved Byooviz, a VEGF inhibitor, for intravitreal injection to treat neovascular age-related macular degeneration, macular ed…
FDA approves Byooviz to treat three eye conditions causing vision loss from leaky blood vessels in the retina.
FDA Approves Focinvez (fosaprepitant) for Prevention of Chemotherapy-Induced Nausea and Vomiting
FDA approves a new intravenous drug to help prevent nausea and vomiting from chemotherapy
The FDA has approved Focinvez, a substance P/NK1 receptor antagonist, for the prevention of acute and delayed nausea and vomiting associated…
FDA approves new IV drug to prevent severe nausea and vomiting from chemotherapy in adults and children 6 months and older.
FDA Approves Depakote Sprinkle Capsules (valproate) for Monotherapy and Adjunctive Therapy of Complex Partial and Absence Seizures
FDA approves a new sprinkle capsule form of the epilepsy drug Depakote
The FDA approved Depakote Sprinkle Capsules (valproate) for monotherapy and adjunctive therapy of complex partial seizures and simple and co…
FDA approves a sprinkle capsule form of Depakote that patients can open and mix with soft food to help those who struggle to swallow pills.
FDA Approves Depakote ER (divalproex sodium) for Acute Manic or Mixed Episodes in Bipolar Disorder
FDA approves a new once-daily pill for treating manic episodes in bipolar disorder
The FDA has approved Depakote ER, an extended-release valproate, for the acute treatment of manic or mixed episodes associated with bipolar …
FDA approves a new once-daily pill for short-term treatment of severe manic episodes in adults with bipolar I disorder.
FDA Approves Valproate Sodium Injection (valproate sodium) for IV Use in Complex Partial and Absence Seizures
FDA approves an injectable version of an existing seizure medicine for short-term use
The FDA approved Valproate Sodium Injection as an intravenous alternative when oral valproate is temporarily not feasible.
FDA approves an injectable seizure medicine for short-term use when patients can't swallow pills due to surgery or stomach issues.
FDA Approves Depakote (divalproex sodium) for Manic Episodes Associated with Bipolar Disorder
FDA approves Depakote for treating manic episodes in bipolar disorder
The FDA approved Depakote (divalproex sodium) for the treatment of manic episodes associated with bipolar disorder.
FDA approves Depakote for treating manic episodes in hospitalized adults with bipolar disorder, offering doctors a new option for managing a…
FDA Approves Xarelto (rivaroxaban) for multiple indications including stroke prevention in nonvalvular atrial fibrillation and treatment of VTE
FDA approves a new blood thinner called Xarelto for several heart and clot conditions
The FDA approved rivaroxaban (Xarelto), a factor Xa inhibitor, for multiple indications including reducing stroke risk in nonvalvular atrial…
FDA approves new blood thinner Xarelto to prevent dangerous clots in heart conditions, deep vein issues, and after major surgeries.
FDA Approves Children's Zyrtec Allergy (cetirizine) for Symptoms of Upper Respiratory Allergies
FDA approves a chewable allergy medicine for children called Children's Zyrtec Allergy
The FDA approved Children's Zyrtec Allergy (cetirizine) for temporarily relieving symptoms of hay fever or other upper respiratory allergies…
FDA approves chewable allergy medicine for kids as young as 2 to help with runny nose, sneezing, and itchy eyes from hay fever.
FDA Approves Ringer's In Plastic Container (Ringer's solution) for parenteral replacement of extracellular fluid and electrolyte losses
The FDA approved a new intravenous fluid called Ringer's In Plastic Container
The FDA approved Ringer's In Plastic Container for parenteral replacement of extracellular losses of fluid and electrolytes, as required by …
FDA approves new IV fluid to replace lost water and minerals like sodium and potassium for patients needing hydration after surgery or from …
FDA Approves Xarelto (rivaroxaban) for Thromboprophylaxis in Pediatric Patients After Fontan Procedure
FDA approves Xarelto to help prevent blood clots in children with certain heart conditions
The FDA approved rivaroxaban (Xarelto) for thromboprophylaxis in pediatric patients aged 2 years and older with congenital heart disease who…
FDA approves Xarelto to prevent dangerous blood clots in children aged 2 and older born with heart defects who have had Fontan surgery.
FDA Approves Marinol (dronabinol) for AIDS-Related Anorexia and Chemotherapy-Induced Nausea/Vomiting
FDA approves a new drug called Marinol to help with AIDS-related weight loss and chemotherapy nausea
The FDA has approved Marinol (dronabinol) for two indications in adults: anorexia associated with weight loss in patients with AIDS, and nau…
The FDA approved Marinol to treat AIDS-related weight loss and severe chemotherapy nausea that standard treatments couldn't control.
FDA Approves Winrevair for Pulmonary Arterial Hypertension (PAH) in Adults
FDA approves a new treatment for a serious lung condition called pulmonary arterial hypertension
The FDA has approved Winrevair for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to improve exercise capac…
A new FDA-approved injection helps adults with pulmonary arterial hypertension exercise longer, improve daily life, and lower the risk of ho…
FDA Approves Elrexfio for Relapsed or Refractory Multiple Myeloma After Four Prior Lines of Therapy
The FDA approved a new treatment for a type of blood cancer called multiple myeloma
The FDA has approved Elrexfio, a bispecific BCMA-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myelom…
A new FDA-approved treatment helps shrink multiple myeloma in patients who have already tried at least four other therapies.
FDA Approves Methylphenidate Hydrochloride Extended-Release Tablets for ADHD and Narcolepsy
The FDA has approved a new, longer-acting generic version of a common ADHD and narcolepsy medication
The FDA has approved methylphenidate hydrochloride extended-release tablets for the treatment of Attention Deficit Hyperactivity Disorder (A…
The FDA approved a new generic ADHD and narcolepsy medicine that works for about 8 hours, offering a longer-lasting option for patients 6 ye…
FDA Approves Krazati (adagrasib) for KRAS G12C-Mutated NSCLC and in Combination for Colorectal Cancer
FDA approves a new targeted cancer drug called Krazati for lung and colorectal cancers
The FDA has approved Krazati as a single agent for adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC after at least…
FDA approves Krazati, a new targeted drug for lung and colorectal cancers with a specific genetic change after other treatments fail.