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U.S. FDA Grants Priority Review to Astellas’ New Drug Application for Gilteritinib for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)
May 30, 2018The NDA is based on the ongoing Phase 3 ADMIRAL trial investigating gilteritinib for the treatment of adult patients with FLT3mut+ relapsed or refractory AML. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is November 29, 2
Pharma Sources Insight January 2025
