Mylotarg™ (gemtuzumab ozogamicin) – New orphan drug approval
September 1, 2017 – The FDA announced the approval of Pfizer’s Mylotarg (gemtuzumab ozogamicin), for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults, and for the treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older.
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