FDA — authorised 23 October 2025
- Application: BLA761440
- Marketing authorisation holder: GLAXOSMITHKLINE LLC
- Status: approved
🇺🇸 Blenrep in United States
FDA authorised Blenrep on 23 October 2025
Marketing authorisations
FDA
- Status: approved
Blenrep 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 Blenrep approved in United States?
Yes. FDA authorised it on 23 October 2025; FDA has authorised it.
Who is the marketing authorisation holder for Blenrep in United States?
GLAXOSMITHKLINE LLC holds the US marketing authorisation.