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BRIEF-FDA Grants Priority Review for Biologics License Application (BLA) and EMA Accepts Marketing Authorisation Application (MAA) for Apitegromab as a Treatment for Spinal Muscular Atrophy

Reuters
03-25
BRIEF-FDA Grants Priority Review for Biologics License Application <a href="https://laohu8.com/S/BLA.AU">$(BLA.AU)$</a> and EMA Accepts Marketing Authorisation Application <a href="https://laohu8.com/S/MAA">$(MAA)$</a> for Apitegromab as a Treatment for Spinal Muscular Atrophy

March 25 (Reuters) - Scholar Rock Holding Corp SRRK.O:

  • FDA GRANTS PRIORITY REVIEW FOR BIOLOGICS LICENSE APPLICATION (BLA) AND EMA ACCEPTS MARKETING AUTHORISATION APPLICATION (MAA) FOR APITEGROMAB AS A TREATMENT FOR SPINAL MUSCULAR ATROPHY

  • SCHOLAR ROCK HOLDING CORP - FDA PDUFA DATE FOR APITEGROMAB SET FOR SEPTEMBER 22, 2025

  • SCHOLAR ROCK HOLDING CORP - PLANS U.S. COMMERCIAL LAUNCH IN 2025

Source text: ID:nBw1KGRFLa

Further company coverage: SRRK.O

((Reuters.Briefs@thomsonreuters.com;))

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