Posted by Michael Wonder on 29 Aug 2024
FDA grants priority review to SpringWorks Therapeutics’ new drug application for mirdametinib for the treatment of adults and children with neurofibromatosis type 1-associated plexiform neurofibromas
28 August 2024 - PDUFA target action date of 28 February 2025.
SpringWorks Therapeutics announced today that the US FDA has accepted the Company’s new drug application for mirdametinib, an investigational MEK inhibitor, for the treatment of adult and paediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas.
