FDA Approves Fayuvi (rebisufligene etisparvovec-hopf) Gene Therapy for the Treatment for Sanfilippo Syndrome Type A (MPS IIIA)
NOVATO, Calif., Sept. 17, 2026 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the U.S. Food and Drug Administration (FDA) granted standard full approval of Fayu
FDA Approves Bexlutry (lutetium Lu 177 dotatate) for Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors
Boston, MA – 14 September, 2026 -- Curium™ announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Bexlutry™ lutetium Lu 177 dotatate injection
FDA Approves Pixclara (floretyrosine F 18) FET-PET Imaging Agent for Glioma
Melbourne (Australia) and Indianapolis, IN (United States) -- September 14, 2026 -- Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug App
FDA Approves Isembyld (apitegromab-mstn) Muscle-Targeted Treatment for Children and Adults with Spinal Muscular Atrophy (SMA)
CAMBRIDGE, Mass.--(BUSINESS WIRE) -- September 11, 2026 -- Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitat
FDA Grants Accelerated Approval to Etcamah (camizestrant) in Combination with a CDK4/6 Inhibitor for the Treatment of Advanced HR-Positive Breast Cancer
September 4, 2026 -- AstraZeneca’s Etcamah (camizestrant) in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (abemaciclib, palbociclib or ribociclib) has been approved in the US for the
FDA Approves Zanvastro (zilganersen) for the Treatment of Alexander Disease
CARLSBAD, Calif. -- (BUSINESS WIRE) -- September 3, 2026 -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has approved Zanvastro (zilganer
FDA Approves Mimrylo (rusfertide) for the Treatment of Polycythemia Vera
OSAKA, Japan and CAMBRIDGE, Massachusetts, August 28, 2026 -- Takeda (TSE:4502/NYSE:TAK) announced U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA)* for Mimrylo (rusf
FDA Approves Bixlenvo (bictegravir and lenacapavir) for the Treatment of HIV in Adults Who Are Virologically Suppressed
FOSTER CITY, Calif.--(BUSINESS WIRE) -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg), t
FDA Approves Lisraya (brepocitinib) for the Treatment of Adults with Dermatomyositis
BASEL, Switzerland and LONDON and NEW YORK, August 27, 2026 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today announced that the U.S. Food and Drug Administration (FDA) has approved Lisraya (brepocitin
FDA Approves Rasonque (daraxonrasib), the First Broad RAS-Targeted Medicine in Metastatic Pancreatic Cancer
REDWOOD CITY, Calif., Aug. 26, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a global commercial-stage oncology company dedicated to discovering, developing and delivering innova
FDA Approves Pasatru (garetosmab-grts) for the Treatment of Fibrodysplasia Ossificans Progressiva
TARRYTOWN, N.Y., August 19, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has granted approval for Pasatru™ (garet
FDA Grants Accelerated Approval for Genglycos (pariglasgene brecaparvovec-opnr) Gene Therapy for the Treatment of Glycogen Storage Disease Type Ia
NOVATO, Calif., August 19, 2026 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Geng
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