81 pipeline articles
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 approval was based on two placebo-controlled trials showin…
The FDA approved Caplyta (lumateperone) for treating schizophrenia in adults. It is a once-daily pill that works without needing to adjust t…
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. It c…
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 drug is taken once daily upon awakening and may last up …
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 recommended starting dose is 3…
The FDA has approved Vyvanse (lisdexamfetamine) for moderate to severe binge eating disorder in adults. It was already approved for ADHD. Th…
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. I…
The FDA approved Metronidazole Injection USP for serious infections caused by anaerobic bacteria. It treats conditions like abdominal, skin,…
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). It is the first treatment th…
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 approval was based on clinical stu…
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. It is used with other drugs for metastatic, locally advanced, or earl…
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. It is a GABA-A receptor positive modulator taken once daily fo…
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. T…
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. This is …
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. It works for cancers that have too much of…
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. It is a biologic drug that targets inf…
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. This inte…
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. The …
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. It is a…
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 approval is based on a 48-week…
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. This approv…
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…
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). Efficacy wa…
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. It is indicated f…
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. The approval was based o…
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.