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FDA Grants Priority Review to SpringWorks Therapeutics' New Drug Application for Mirdametinib for the Treatment of Adults and Children with NF1-PN
SWTXSpringWorks Therapeutics(SWTX) GlobeNewswire News Room·2024-08-28 10:30

– PDUFA target action date of February 28, 2025 – – EU Marketing Authorization Application also validated by European Medicines Agency – STAMFORD, Conn., Aug. 28, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for mirdametinib, an investigational MEK inhibitor, for the treatment ...