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
FDA Approves Osenvelt (denosumab-bmwo), a Biosimilar to Xgeva
JERSEY CITY, N.J., March 3, 2025 /PRNewswire/ -- Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved Osenvelt (CT-P41, denosumab-bmwo), a biosimilar referencing Xge
FDA Approves Miudella (copper intrauterine system) for the Prevention of Pregnancy
ROSWELL, GA, February 24, 2025 - Sebela Women’s Health Inc., a part of Sebela Pharmaceuticals, today announced that the U.S. Food and Drug Administration (FDA) granted approval of Miudella (copper int
FDA Approves Ctexli (chenodiol) for Cerebrotendinous Xanthomatosis
February 21, 2025 -- Today, the U.S. Food and Drug Administration approved Ctexli (chenodiol) for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. Ctexli is the first FDA-approved drug
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