Biotech News
Scholar Rock Resubmits Biologics License Application (BLA) to FDA for Apitegromab for Treatment of Children and Adults with Spinal Muscular Atrophy (SMA)
Apitegromab BLA resubmission includes Catalent Indiana LLC (part of Novo Nordisk) and second U.S. -based fill-finish facility, aligned with FDA guidance from March 3, 2026 Type C meeting FDA and Novo Nordisk Q1 2026 interactions resulted in Scholar Rock’s alignment with FDA to resubmit apitegromab