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FDA Issues Complete Response Letter (CRL) for Apitegromab as a Treatment for Patients with Spinal Muscular Atrophy (SMA) Solely Related to Observations Identified at Catalent Indiana LLC Fill-Finish Facility - Scholar Rock

Scholar Rock Announces Plans to Resubmit Apitegromab BLA Following Catalent-Related Concerns In a recent development, Scholar Rock, a biopharmaceutical company, has announced its intention to resubmit the Apitegromab Biologics License Application (BLA) following unresolved issues with Catalent Indiana LLC. While no other approvability concerns were cited in the latest communication

By Lau Chi Fung