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A supplemental biologics license application has been submitted to the FDA for luspatercept for the treatment of adult patients with very low- to intermediate-risk myelodysplastic syndrome–associated anemia with ring sideroblasts who require red blood cell transfusions, and also for adult patients with beta-thalassemia–associated anemia who require such transfusions.

The FDA has added 3 months to the review period for a new drug application for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid leukemia, allowing the agency to review additional data provided by Daiichi Sankyo.