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.
More than a year after a catastrophic shortage of platinum-based chemotherapy drugs swept through the U.S., FDA on June 28 officially removed carboplatin and cisplatin from the drug shortage list.
