Hematological Disorders

Bristol-Meyers Squibb and Acceleron Pharma have announced that US FDA committee will review BMS’s supplemental Biologics License Application (sBLA) for its Reblozyl in MDS. Reblozyl ((luspatercept-aamt) has recently been approved by the regulatory authority to cure a rare type of blood disorder, Beta-thalassemia. Now, the companies are seeking to extend the approval of the therapy to treat adult patients with myelodysplastic syndromes (MDS)- in which bone marrow loses the ability to manufacture RBCs.  MDS is a rare form of the disorder that develops due to the inability of the bone marrow to produce mature blood cells. These blood cells remain in an immatu...