Sarah Silbiger/Getty Images News Bristol Myers Squibb ( NYSE: BMY ) announced Tuesday that the U.S. Food and Drug Administration (FDA) has revised the PDUFA goal date regarding its marketing application for a subcutaneous version of its anti-PD1 cancer therapy, Opdivo (nivolumab).
In May, the FDA accepted the company’s Biologics License Application for injectable nivolumab and issued February 28, 2025, as the Prescription Drug User Fee Act (PDUFA) goal date to complete its review. The updated PDUFA date of December 29, 2024, revises the review timeline. The Princeton, New Jersey-headquartered pharma giant has developed injectable nivolumab to target all FDA-approved indications licensed under intravenous Opdivo.
Bristol Myers ( BMY ) said that if approved, the new therapy developed in partnership with Halozyme ( NASDAQ: HALO ) has the potential to become the first and only subcutaneously administered PD-1 inhibitor. More on Bristol-Myers Squibb Bristol-Myers Squibb Company (BMY) Bank of America Global Healthcare Conference 2024 Transcript Bristol-Myers Squibb Company (BMY) Presents at Guggenheim Securities Radiopharmaceuticals Day (Transcript) Bristol-Myers Squibb: A Lost Decade? Tudor Investment's top buys and sells in Q1 Bristol Myers' Breyanzi gains additional indication for follicular lymphoma.