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Opdivo in

Updated ยทnext FDA decision on the calendar

Opdivo in The FDA approved it on Mar 20, 2026. 1 FDA decision on record below. Every date links its source.

BMY catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

We track 1 catalyst event for this program: 0 upcoming and 1 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.

Catalyst history

PDUFA · Mar 20, 2026 ✓ ApprovedBMY

Questions

When is Opdivo in's next FDA decision or readout?

No upcoming catalyst is on our calendar for Opdivo in; 1 FDA decision is on record below.

What happened at Opdivo in's most recent FDA decision?

On Mar 20, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Has Opdivo in been approved by the FDA?

Yes. The FDA approved an application for Opdivo in on Mar 20, 2026; the decision page linked above carries the source.

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.

Facts and dates only; not investment advice. Verify against primary FDA, SEC and company filings. pdufa.bio is not affiliated with the FDA.
About · Corrections · Methodology

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.

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