Biotech News
Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan
Under FDA guidance, Scholar Rock has successfully removed Catalent Indiana LLC (part of Novo Nordisk) as a commercial fill-finish facility from apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA); FDA review of BLA progressing well with Scholar Rock’s alternate