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Scholar Rock Receives News on Biologics License Application (BLA) for Apitegromab from the U.S. FDA
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Scholar Rock Receives News on Biologics License Application (BLA) for Apitegromab from the U.S. FDA
Yesterday, Scholar Rock shared an SMA community update letter on their Biologics License Application (BLA) for apitegromab in SMA. As shared on September 23, 2025, Scholar Rock received a Complete Response Letter (CRL) from the FDA for the apitegromab BLA in SMA. As a reminder, the CRL was solely related to manufacturing observations identified at a third-party vialing facility, Catalent Indiana, LLC (owned by Novo Nordisk). Importantly, the CRL…
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