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

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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

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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

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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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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

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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

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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

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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

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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

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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

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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

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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.

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