drug approval

(NASDAQ:AMRX) BRIDGEWATER, N.J., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of risperidone extended-release injectable suspension 12.5 mg/vial, 25 mg/vial, 37.5 mg/vial and 50 mg/vial, which references Janssen’s Risperdal Consta®. The product is eligible for 180-day exclusivity under the FDA’s Competitive Generic Therapy (CGT) designation. Product launch is planned for the fourth quarter of 2025.

(NASDAQ:SNY) Sanofi’s Wayrilz approved in US as first BTK inhibitor for immune thrombocytopenia

(6576.TWO) TAIPEI, Aug. 28, 2025 /PRNewswire/ -- Foresee Pharmaceuticals (6576.TWO), ("Foresee") announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for CAMCEVI ETM (leuprolide mesylate 21 mg, ready-to-use long-acting injectable (LAI)...

Teva Announces FDA Approval and Launch of Generic Saxenda® (liraglutide injection) – First Generic GLP-1 Indicated for Weight Loss

OGSIVEO is the first and only therapy to receive marketing authorization in the EU for the treatment of desmoid tumors OGSIVEO is the first and only therapy to receive marketing authorization in the EU for the treatment of desmoid tumors

FORT WORTH, Texas--(BUSINESS WIRE)--Hope Realized: FDA Approves Papzimeos for Adults with Recurrent Respiratory Papillomatosis (RRP)

OMAHA, Neb.--(BUSINESS WIRE)--Amber Specialty Pharmacy, a pioneer in specialty pharmacy for more than 25 years, today announced it is now dispensing BRINSUPRI™ (brensocatib) following the medication’s U.S. Food and Drug Administration (FDA) approval as the first treatment specifically indicated to reduce pulmonary exacerbations in adults and adolescents with non-cystic fibrosis bronchiectasis, a chronic neutrophil-mediated airway disease. “Our nationally recognized clinical program is ready to