🇺🇸 Tevimbra in United States

FDA authorised Tevimbra on 22 April 2025

Marketing authorisations

FDA — authorised 22 April 2025

Application: BLA761232
Marketing authorisation holder: BEIGENE
Indication: Efficacy
Status: approved

The FDA approved Tevimbra, a drug developed by BEIGENE, for its approved indication on 22 April 2025. The application number for this approval is BLA761232. The approval was granted through the standard expedited pathway.

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FDA

Marketing authorisation holder: BEIGENE
Status: approved

Tevimbra 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 Tevimbra approved in United States?

Yes. FDA authorised it on 22 April 2025; FDA has authorised it.

Who is the marketing authorisation holder for Tevimbra in United States?

BEIGENE holds the US marketing authorisation.