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
FDA Approves Vimkunya (chikungunya vaccine, recombinant) for Prevention of Disease Caused by Chikungunya Virus
COPENHAGEN, Denmark, February 14, 2025 -- Bavarian Nordic A/S (OMX: BAVA) announced today that the U.S. Food and Drug Administration (FDA) has approved Vimkunya (Chikungunya Vaccine, Recombinant) for
FDA Approves Merilog (insulin-aspart-szjj), a Biosimilar to NovoLog
February 14, 2025 -- Today, the U.S. Food and Drug Administration approved Merilog (insulin-aspart-szjj) as biosimilar to NovoLog (insulin aspart) for the improvement of glycemic control in adults and
FDA Approves Ospomyv (denosumab-dssb), a Biosimilar to Prolia
INCHEON, Korea – Feb 16, 2025 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Ospomyv (denosumab-d
FDA Approves Xbryk (denosumab-dssb), a Biosimilar to Xgeva
INCHEON, Korea – Feb 16, 2025 -- Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Xbryk (denosumab-ds
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 Gomekli (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN
STAMFORD, Conn., Feb. 11, 2025 -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the U.S.
FDA Approves Emblaveo (aztreonam and avibactam) for the Treatment of Adults With Complicated Intra-Abdominal Infections
NORTH CHICAGO, Ill., Feb. 7, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved Emblaveo™ (aztreonam and avibactam), as the first an
FDA Approves Onapgo (apomorphine hydrochloride) for the Treatment of Motor Fluctuations in Adults with Advanced Parkinson’s Disease
ROCKVILLE, Md., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of cen
FDA Approves Journavx (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain
BOSTON--(BUSINESS WIRE)--Jan. 30, 2025 -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved Journavx (suzetrigine), an or
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