🇺🇸 MONJUVI in United States

FDA authorised MONJUVI on 31 July 2020

Marketing authorisation

FDA — authorised 31 July 2020

  • Application: BLA761163
  • Marketing authorisation holder: MORPHOSYS US INC
  • Local brand name: MONJUVI
  • Indication: SOLUTION — INTRAVENOUS
  • Status: approved

The FDA approved MONJUVI, a drug developed by MORPHOSYS US INC, for marketing in the United States on 18 June 2025. The approval was granted under the standard expedited pathway. The application number for this approval is BLA761163.

Read official source →

MONJUVI 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 MONJUVI approved in United States?

Yes. FDA authorised it on 31 July 2020.

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

MORPHOSYS US INC holds the US marketing authorisation.