-Bristol Myers Squibb and Acceleron Pharma Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion, recommending the approval of Reblozyl (luspatercept) for the treatment of: 1.Adult patients with transfusion-dependent anemia due to very low-, low- and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response or are ineligible for erythropoietin-based therapy.2. Adult patients with transfusion-dependent anemia associated with beta thalassemia.
Adial Pharmaceuticals, Inc., announced the publication of a peer-reviewed article highlighting the promising clinical results, strong safety profile and high compliance among patients administered AD 04 (low-dose ondansetron), the Company’s lead investigational new drug product being developed for the treatment of Alcohol Use Disorder (AUD)
HER2-low breast cancer has recently emerged as a targetable subset of breast tumors, based on the evidence from clinical trials of novel anti-HER2 antibody-drug conjugates.
Following recent discussions with the FDA, BMS announced the voluntary withdrawal of the U.S. supplemental Biologics License Application (sBLA) for...