Bristol-Myers: FDA accepts sBLA for Opdivo

Bristol Myers Squibb announced that the U.S. FDA has accepted the supplemental Biologics License Application and the European Medicines Agency has validated the Type II Variation Marketing Authorization Application for Opdivo as monotherapy in the adjuvant setting for the treatment of patients with completely resected stage IIB or IIC melanoma. In the U.S., the FDA has assigned a Prescription Drug User Fee Act date of October 13, 2023. In Europe, the EMA’s validation of the application confirms the submission is complete and begins the start of the EMA’s centralized review process.