FDA — authorised 29 December 2020
- Application: BLA125554
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Indication: Labeling
- Status: approved
🇺🇸 Opdivo in United States
FDA authorised Opdivo on 29 December 2020
Marketing authorisations
FDA — authorised 18 March 2022
- Application: BLA761234
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Indication: Type 1 - New Molecular Entity
- Status: approved
FDA — authorised 27 October 2025
- Application: BLA761381
- Marketing authorisation holder: BRISTOL-MYERS SQUIBB
- Indication: Efficacy
- Status: approved
The FDA approved Opdivo, a medication developed by Bristol-Myers Squibb, on 27 October 2025. The approval was granted under the standard expedited pathway, with application number BLA761381. This approval allows Bristol-Myers Squibb to market Opdivo for its approved indication in the United States.
Opdivo in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Opdivo approved in United States?
Yes. FDA authorised it on 29 December 2020; FDA authorised it on 18 March 2022; FDA authorised it on 27 October 2025.
Who is the marketing authorisation holder for Opdivo in United States?
BRISTOL MYERS SQUIBB holds the US marketing authorisation.