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.
FDA Center for Drug Evaluation and Research is soliciting grant applications from independent organizations to support meetings that bring together a broad range of stakeholders to explore, research, and address issues related to medical products, policy, and surveillance methods and systems.
