07:58 AM EDT, 05/06/2024 (MT Newswires) -- Bristol-Myers Squibb ( BMY ) said Monday that separate applications for Opdivo have been accepted by the US Food and Drug Administration and the European Medicines Agency.

The FDA has accepted the biologics license application for the subcutaneous formulation of Opdivo co-formulated with Halozyme's recombinant human hyaluronidase while the EMA has validated the type 2 application for Opdivo plus Yervoy to treat adults with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer, Bristol-Myers said.

The FDA assigned a Prescription Drug User Fee Act target date of Feb. 28, 2025, according to the company.

The EMA's validation of the application confirms the submission is complete and marks the beginning of the centralized review process, Bristol-Myers added.

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