Biohaven’s Taldefgrobep Alfa Receives Fast Track Designation from FDA for Treating Spinal Muscular Atrophy
Biohaven Ltd. has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its novel anti-myostatin adnectin, taldefgrobep alfa, for treating spinal muscular atrophy (SMA). ...
U.S. FDA Grants Fast Track Designation to Artiva Biotherapeutics’ Lead Program AB-101
Artiva Biotherapeutics, Inc., a clinical-stage company whose mission is to provide highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, announces that the U.S. FDA has ...
FDA Approves Apellis’ SYFOVRE™ (pegcetacoplan injection) for Geographic Atrophy (GA)
Apellis Pharmaceuticals, Inc. announced today that SYFOVRE™ (pegcetacoplan injection) has been approved by the United States Food and Drug Administration (FDA) for the treatment of geographic atrophy ...
Bluebird bio Receives EC Approval for SKYSONA™ for Early Cerebral Adrenoleukodystrophy (CALD)
Bluebird bio, Inc. today announced that The European Commission (EC) had approved SKYSONA™ (elivaldogene autotemcel, Lenti-D™), one-time gene therapy for the treatment of early Cerebral Adrenoleukodys ...
FDA approves Apic Bio’s APB-102 for SOD1 Amyotrophic lateral sclerosis
Apic Bio, Inc. today announced that the US FDA had cleared its IND application for APB-102 to treat SOD1 Amyotrophic lateral sclerosis (ALS) – a common cause of familial ALS. APB-102 is a next-generat ...