FDA — authorised 18 March 2022
- Application: BLA761234
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Status: supplemented
🇺🇸 Opdualag in United States
FDA authorised Opdualag on 18 March 2022
Marketing authorisations
FDA
- Status: approved
Opdualag 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 Opdualag approved in United States?
Yes. FDA authorised it on 18 March 2022; FDA has authorised it.
Who is the marketing authorisation holder for Opdualag in United States?
BRISTOL MYERS SQUIBB holds the US marketing authorisation.