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
FDA Approves Steqeyma (ustekinumab-stba), a Biosimilar to Stelara
JERSEY CITY, N.J., Dec. 17, 2024 -- Celltrion announced today that the U.S. Food and Drug Administration (FDA) has approved Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), for subc
FDA Approves Crenessity (crinecerfont) for the Treatment of Children and Adults with Classic Congenital Adrenal Hyperplasia
SAN DIEGO, Dec. 13, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration has approved Crenessity (crinecerfont) capsules and oral solu
FDA Grants Accelerated Approval to Bizengri (zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NRG1+ Non–Small Cell Lung Cancer
UTRECHT, The Netherlands and CAMBRIDGE, Mass., Dec. 04, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) [Merus, the Company, we, or our], a clinical-stage oncology company developing innovative, fu
FDA Approves Yesintek (ustekinumab-kfce), a Biosimilar to Stelara
Bengaluru, Karnataka, India, December 01, 2024 -- Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced toda
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