Scholar Rock shifts its FDA review for SMA treatment apitegromab to a secondary facility, keeping the September 30 approval date on schedule.

Scholar Rock Announces FDA Review of Apitegromab Biologics License Application (BLA) for Spinal Muscular Atrophy (SMA) to Progress with Second Fill-Finish Facility; Approval…

Scholar Rock has shed Novo Nordisk’s troubled Cata | Scholar Rock has dropped Novo Nordisk’s troubled Catalent facility as a contract manufacturer in its FDA refiling for…