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Will the FDA approve SpringWorks' NDA for Mirdametinib for NF1-PN by the end of 2024?
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Soleno Therapeutics•FDA•New Drug Application•NDA•DCCR•Diazoxide Choline•PDUFA•Advisory Committee•AdComm•SpringWorks Therapeutics•Mirdametinib
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FDA official announcement or press release
Story
FDA Accepts Soleno's NDA for DCCR with PDUFA 12/27/24 and Grants Priority Review to SpringWorks' Mirdametinib
Aug 28, 2024, 10:34 AM
Soleno Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for DCCR (Diazoxide Choline) extended-release tablets, designed to treat Prader-Willi Syndrome, for priority review. The Prescription Drug User Fee Act (PDUFA) date for this application is set for December 27, 2024. The FDA also plans to hold an Advisory Committee (AdComm) meeting regarding this application. In a separate development, the FDA has granted priority review to SpringWorks Therapeutics' NDA for Mirdametinib, intended for the treatment of adults and children with Neurofibromatosis Type 1-Associated Plexiform Neurofibromas (NF1-PN). SpringWorks Therapeutics' stock saw a pre-market increase of 2.1% following this announcement.
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