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.”

Discussion

Sign in to join the discussion. Comments loading…