Scholar Rock Removes Catalent Indiana From Apitegromab BLA After FDA OAI Classification; FDA Review Remains On Track for Sept. 30 PDUFA Using Second Fill-Finish Site
Today, August 7, 2026, Scholar Rock received customer notification from Catalent Indiana LLC (part of Novo Nordisk) that FDA classified the April 2026 site inspection of Catalent Indiana fill-finish facility as Official
Scholar Rock's medicine application hit a bump—the FDA found problems at one factory—but the company switched to a different factory to keep things on schedule. Watch how well the new factory works, since that now matters more for whether the medicine gets approved.
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