Nivolumab is a Bristol-Myers Squibb Company program. Its next catalyst is a Readout in Dec 2026. 2 FDA decisions on record below. Every date links its source.
Nivolumab is marketed as Opdivo (nivolumab); the events below include those tracked under the brand name. Sponsor: Bristol-Myers Squibb Company (BMY). We track 5 catalyst events for this program: 2 upcoming and 3 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
Not affiliated with or endorsed by the FDA. pdufa.bio is an independent publication with no affiliation with, endorsement by, sponsorship by, or connection to the U.S. Food and Drug Administration or any other government agency. “FDA”, “PDUFA” and all company, drug and ticker names are used descriptively and remain the property of their respective owners.
Informational and educational purposes only. Not investment advice. Nothing on this page is investment, legal, tax or medical advice, or an offer or solicitation to buy or sell any security. pdufa.bio is not a registered investment adviser or broker-dealer and does not recommend trades or publish individual-drug approval probabilities. Verify every date and outcome against primary FDA, SEC or company filings. Data is provided as is, without warranty of any kind, and past behaviour does not predict future outcomes.