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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

FDA Approves Romvimza (vimseltinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumor

Osaka, Japan and Waltham, Massachusetts, February 14, 2025 -- Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino; “Ono”) announced that the U.S. Food and Drug Administr

FDA Approves Penmenvy (meningococcal groups A, B, C, W, and Y vaccine) for Prevention of Invasive Meningococcal Disease Caused by Serogroups A, B, C, W, and Y

London, UK - 15 February 2025 -- GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) for use i