- The European Medicines Agency's advisory group CHMP has adopted a positive opinion recommending approval of Astellas Pharma Europe B.V.'s (OTCPK:ALPMF) Xospata (gilteritinib) for the treatment of adult patients with FLT3 mutation-positive acute myeloid leukemia (AML).
- A positive opinion from the European Commission usually takes ~60 days.
European advisory group backs Astellas Pharma's gilteritinib for certain type of leukemia
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