FDA — authorised 4 December 2024
- Application: BLA761352
- Marketing authorisation holder: MERUS N.V.
- Local brand name: BIZENGRI
- Indication: INJECTION — SOLUTION
- Status: approved
🇺🇸 BIZENGRI in United States
FDA authorised BIZENGRI on 4 December 2024
Marketing authorisations
FDA
- Status: approved
BIZENGRI in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is BIZENGRI approved in United States?
Yes. FDA authorised it on 4 December 2024; FDA has authorised it.
Who is the marketing authorisation holder for BIZENGRI in United States?
MERUS N.V. holds the US marketing authorisation.