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Novo’s Catalent plant ditched in FDA refiling of SMA drug - Fierce PharmaFierce Pharma · Mon, 10 Aug 2026 14:06:15 GMTScholar Rock shifts apitegromab BLA to second fill-finish site after Catalent FDA inspection - AllSciAllSci · Mon, 10 Aug 2026 10:21:59 GMTScholar 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 - BioSpaceBioSpace · Mon, 10 Aug 2026 02:16:42 GMTScholar Rock drops Catalent facility from marketing application for muscle weakness drug - 1470 & 100.3 WMBD1470 & 100.3 WMBD · Sat, 08 Aug 2026 02:32:33 GMT