🇺🇸 Bizengri in United States

FDA authorised Bizengri on 4 December 2024

Marketing authorisations

FDA — authorised 4 December 2024

  • Application: BLA761352
  • Marketing authorisation holder: MERUS N.V.
  • Local brand name: BIZENGRI
  • Indication: INJECTION — SOLUTION
  • Status: approved

The FDA approved Bizengri, a new molecular entity, on 4 December 2024, under standard expedited pathway. The marketing authorisation holder is MERUS N.V. The approval was granted for the treatment of a specified indication. Further details on the indication and local brand name are not available.

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FDA

  • Marketing authorisation holder: MERUS N.V.
  • 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 Oncology 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.