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
ReutersMar 25, 2025 11:33 AM
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
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