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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

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

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

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

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

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

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

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

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

FDA Approves Tryngolza (olezarsen) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome

CARLSBAD, Calif., Dec. 19, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has approved Tryngolza (olezarsen) as an adj

FDA Approves Ryoncil (remestemcel-L-rknd) Mesenchymal Stromal Cell Therapy for Steroid-Refractory Acute Graft Versus Host Disease

NEW YORK, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced the Food and Drug Admini

FDA Approves Ensacove (ensartinib) for ALK-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

On December 18, 2024 -- the Food and Drug Administration approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or me