pdufa.bio

Opdivo (nivolumab)

Updated ยทnext FDA decision on the calendar

Opdivo (nivolumab) 2 FDA decisions on record below. Every date links its source.

BMY catalyst hub

About this program

We track 2 catalyst events for this program: 0 upcoming and 2 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 · Apr 8, 2025 ✓ ApprovedBMYPDUFA · Apr 11, 2025 ✓ ApprovedBMY

Questions

When is Opdivo (nivolumab)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for Opdivo (nivolumab); 2 FDA decisions are on record below.

What happened at Opdivo (nivolumab)'s most recent FDA decision?

On Apr 11, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Has Opdivo (nivolumab) been approved by the FDA?

Yes. The FDA approved an application for Opdivo (nivolumab) on Apr 11, 2025; 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.