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FDA Approves Zevaskyn (prademagene zamikeracel) Gene Therapy for Patients with Recessive Dystrophic Epidermolysis Bullosa

CLEVELAND, April 29, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the U.S. Food and Drug Administration (FDA) has approved Zevaskyn (pronounced as ‘ZEE-vah-skin’) (

FDA Approves Penpulimab-kcqx for the Treatment of Advanced Nasopharyngeal Carcinoma

HONG KONG, April 24, 2025 -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is excited to announce that the U.S. Food and Drug Administration (FDA) has approved its differentiate

FDA Approves Jobevne (bevacizumab-nwgd), a Biosimilar to Avastin

BRIDGEWATER, New Jersey and BENGALURU, Karnataka, India, April 10, 2025 -- Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the U.S. Food an

FDA Grants Accelerated Approval for Vanrafia (atrasentan) for Proteinuria Reduction in Primary IgA Nephropathy

Basel, April 3, 2025 -- Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Vanrafia® (atrasentan), a potent and selective endothelin A (ETA) recept

FDA Approves Qfitlia (fitusiran) to Treat Hemophilia A or B With or Without Inhibitors

Paris, March 28, 2025. -- The US Food and Drug Administration (FDA) has approved Qfitlia (fitusiran), the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the freq

FDA Approves Vykat XR (diazoxide choline) to Treat Hyperphagia in Prader-Willi Syndrome

REDWOOD CITY, Calif., March 26, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today a

FDA Approves Blujepa (gepotidacin) for the Treatment of Uncomplicated Urinary Tract Infections

London, UK -- 25 March 2025 -- GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Blujepa (gepotidacin) for the treatment of female adults (≥40 kg) and

FDA Approves Gozellix (kit for the preparation of gallium Ga 68 gozetotide injection) for Prostate Cancer Imaging

Melbourne Australia | 21 March 2025 -- Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Gozellix® (TLX007-CDx, kit

FDA Approves Arbli (losartan potassium) Oral Suspension as the First Ready-to-Use Oral Liquid Losartan in the U.S.

TAMPA, FL, March 18, 2025 (GLOBE NEWSWIRE) -- Scienture Holdings, Inc. NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value

FDA Approves Omlyclo (omalizumab-igec), an Interchangeable Biosimilar to Xolair

JERSEY CITY, N.J., March 9, 2025 /PRNewswire/ -- Celltrion today announced the U.S. Food and Drug Administration (FDA) approved Omlyclo® (omalizumab-igec) as the first and only biosimilar designated a

FDA Approves Encelto (revakinagene taroretcel-lwey) for the Treatment of Macular Telangiectasia Type 2 (MacTel)

CUMBERLAND, R.I.--(BUSINESS WIRE) -- Neurotech Pharmaceuticals, Inc., a private biotech company focused on developing transformative therapies for chronic eye diseases, announced that the U.S. Food an

FDA Approves Stoboclo (denosumab-bmwo), a Biosimilar to Prolia

JERSEY CITY, N.J., March 3, 2025 /PRNewswire/ -- Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved Stoboclo (CT-P41, denosumab-bmwo), a biosimilar referencing Pro