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FDA Alerts

FDA Approves Gemtuzumab Ozogamicin for CD33-Positive AML

The U.S. Food and Drug Administration approved gemtuzumab ozogamicin (Mylotarg, Pfizer Inc.) for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and for treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older.
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