Biologics License Application
Cellares’ cell therapy factory-in-a-box scores coveted advanced manufacturing technology tag from FDA
Cell Therapy, Advanced Manufacturing Technology, United States Food and Drug Administration, Technology, Identifier, Cell Shuttle, production, Cellares, Biologics License Application, Investigational New Drugs
Outlook Therapeutics to Resubmit BLA for ONS-5010 Despite Missing Primary Endpoint in NORSE EIGHT Trial
Outlook Therapeutics, ONS-5010, Lytenava, Wet Age-Related Macular Degeneration (wet AMD), Biologics License Application (BLA), NORSE EIGHT Trial, FDA Approval
Regenxbio Advances Duchenne Muscular Dystrophy Gene Therapy to Pivotal Studies, Potentially Challenging Sarepta’s Dominance
Regenxbio, Sarepta Therapeutics, Duchenne Muscular Dystrophy (DMD), Gene Therapy, RGX-202, Elevidys, Pivotal Studies, Biologics License Application (BLA), FDA Approval
Scholar Rock’s Stock Skyrockets 300% Following Successful Phase III Trial of Apitegromab for Spinal Muscular Atrophy
Scholar Rock, Spinal Muscular Atrophy (SMA), Apitegromab, Phase III Trial, Stock Surge, Biologics License Application (BLA), Marketing Authorisation Application (MAA)