FDA — authorised 21 October 2022
- Marketing authorisation holder: ASTRAZENECA AB
- Status: approved
🇺🇸 Imjudo in United States
FDA authorised Imjudo on 21 October 2022
Marketing authorisations
FDA — authorised 14 June 2023
- Application: BLA761289
- Marketing authorisation holder: ASTRAZENECA AB
- Indication: Labeling
- Status: approved
Imjudo 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 Imjudo approved in United States?
Yes. FDA authorised it on 21 October 2022; FDA authorised it on 14 June 2023.
Who is the marketing authorisation holder for Imjudo in United States?
ASTRAZENECA AB holds the US marketing authorisation.