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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FDA Approves Datroway (datopotamab deruxtecan-dlnk) for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer

WILMINGTON, Del.-- January 17, 2025 -- Datroway (datopotamab deruxtecan-dlnk) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-posi

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FDA Approves Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) Subcutaneous Injection for Use in Most Previously Approved Solid Tumor Opdivo (nivolumab) Indications

PRINCETON, N.J.--(BUSINESS WIRE) December 27, 2024 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) granted approval for Opdivo Qvantig (nivolumab a

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FDA Approves Alhemo (concizumab-mtci) to Prevent or Reduce Bleeding Episodes in People with Hemophilia A or B with Inhibitors

PLAINSBORO, N.J., Dec. 20, 2024 /PRNewswire/ -- Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) approved Alhemo (concizumab-mtci) injection as a once-daily prophylaxis to

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FDA Approves Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) for the Treatment of Cystic Fibrosis

BOSTON--(BUSINESS WIRE)--Dec. 20, 2024 -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved ALYFTREK (vanzacaftor/tezacaf

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