FDA Approvals
Scholar Rock ditches Novo’s legacy Catalent plant in FDA refiling of SMA drug
FierceBiotech
Aug 12, 2026
FDA News
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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