FDA accepts sBLA and EMA validates Reblozyl as first-line treatment of anemia in lower risk MDS

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FDA accepted the supplemental Biologics License Application sBLA and the European Medicines Agency has validated the Type II Variation Application for Reblozyl (luspatercept-aamt) to expand its current indication to include treatment of anemia without previous use of erythropoiesis-stimulating agents in adult patients with very low- to intermediate-risk myelodysplastic syndromes who may require red blood cell transfusions.

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