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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 apitegromab, a spinal muscular atrophy candidate, after a recent inspection of the plant was classified as “Official Action Indicated.”
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Scholar Rock drops Novo manufacturing site from SMA drug application

Scholar Rock Announces FDA Review of Apitegromab Biologics License Application (BLA) for Spinal Muscular Atrophy (SMA) to Progress with Second Fill-Finish Facility; Approval Decision Anticipated by September 30, 2026 Action Date

Scholar Rock Overcomes Manufacturing Hurdle to Keep Lead Drug FDA Review on Schedule - Scholar Rock Holdi