FDA — authorised 22 April 2021
- Marketing authorisation holder: GLAXOSMITHKLINE
- Status: approved
🇺🇸 Jemperli in United States
FDA authorised Jemperli on 22 April 2021
Marketing authorisations
FDA — authorised 22 April 2021
- Application: BLA761174
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: JEMPERLI
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 August 2021
- Application: BLA761223
- Marketing authorisation holder: GLAXOSMITHKLINE LLC
- Local brand name: JEMPERLI
- Indication: INJECTABLE — INJECTION
- Status: approved
Jemperli 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 Jemperli approved in United States?
Yes. FDA authorised it on 22 April 2021; FDA authorised it on 22 April 2021; FDA authorised it on 17 August 2021.
Who is the marketing authorisation holder for Jemperli in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.