FDA Assigns Review Date for Mirdametinib in Genetic Nerve Condition.

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معلومة اضافية
- الموضوع:
  Therapeutic use of antineoplastic agents; Mitogen-activated protein kinases; Neurofibroma; Rare diseases; Drug therapy; United States. Food & Drug Administration; Neurofibromatosis 1; Treatment duration; Drug approval; Adverse health care events
- نبذة مختصرة :
  The article announces that the FDA has set a Prescription Drug User Fee Act (PDUFA) action date of February 28, 2025, for mirdametinib, an investigational MEK inhibitor for treating neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN). Topics include the drug's regulatory status and potential first approval for adults, the genetic condition it aims to treat, and the clinical trial data supporting its use.