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Benzinga

Business

Vandana Singh

Scholar Rock's Spinal Muscular Atrophy Drug Faces FDA Delay Over Catalent Indiana Inspection

FDA Scholar Rock United States US Food and Drug Administration

Muscular Dystrophy

The U.S. Food and Drug Administration (FDA) on Tuesday issued a Complete Response Letter (CRL) for Scholar Rock’s (NASDAQ: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 (NYSE:NVS) acquired in December 2024.

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Top stories on inkl right now

Flight attendants' union flags safety concerns over Trump's Washington arch

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The union representing flight attendants has raised safety concerns about President Donald Trump's proposed triumphal arch near Ronald Reagan Washington National Airport

The Independent UK

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Venezuelans in South Florida Demand End ICE Partnership as Immigration Crackdown Fuels Midterm Backlash

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One subscription that gives you access to news from hundreds of sites

Already a member? Sign in here

Appeals court reverses convictions in kidnapping and terrorism case involving 3-year-old boy's death

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