FiercePharmaOriginal article
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NDA FilingapitegromabNegative
AI Analysis
Summary
Scholar Rock has dropped Novo Nordisk's Catalent facility as a contract manufacturer in an FDA refiling for spinal muscular atrophy drug apitegromab after the plant received an "Official Action Indicated" classification during inspection.
Outcome Details
FDA refiling after Official Action Indicated inspection classification at Novo Nordisk's Catalent facility
Importance:6/10
Sentiment:
-0.65
regulatoryFDA refilingmanufacturing facility issueOfficial Action Indicatedcontract manufacturing
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Published by FiercePharma on August 10, 2026 10:09 AM