FDA Accepts sBLA of BMS' Reblozyl

The FDA has accepted the supplemental biologics license application (sBLA) and the EMA has validated the type II variation application for luspatercept-aamt (Reblozyl) for the treatment of anemia without prior use of erythropoiesis-stimulating agents in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require red blood cell (RBC) transfusions.