Scholar Rock Removes Catalent Indiana From Apitegromab BLA After FDA OAI Classification; FDA Review Remains On Track for Sept. 30 PDUFA Usin
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 Action Indicated (OAI) Scholar Rock continuing to collaborate closely with FDA and under their guida