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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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

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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

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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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FDA Approves Symbravo (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in Adults

NEW YORK, Jan. 30, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today an

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FDA Approves Avtozma (tocilizumab-anoh), a Biosimilar to Actemra

JERSEY CITY, N.J., Jan. 30, 2025 -- Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved Avtozma® (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and subcutan

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FDA Approves Grafapex (treosulfan) Preparative Regimen for Allogeneic Hematopoietic Stem Cell Transplantation

On January 22, 2025 -- Medexus was informed that the FDA approved Grafapex, an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloH

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