The U.S. Food and Drug Administration (FDA) on Tuesday issued a Complete Response Letter (CRL) for Scholar Rock’s SRRK apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA).The CRL is related to observations identified during a routine general site inspection of Catalent Indiana LLC, a third-party fill-finish facility which Novo Nordisk A/S NVS acquired in December 2024.The observations are not specific to apitegromab.The CRL did not cite any other approvability concerns, includi ...