FDA — authorised 16 December 2020
- Marketing authorisation holder: MACROGENICS INC
- Status: approved
🇺🇸 Margenza in United States
FDA authorised Margenza on 16 December 2020
Marketing authorisations
FDA — authorised 16 December 2020
- Application: BLA761150
- Marketing authorisation holder: MACROGENICS INC
- Indication: Type 1 - New Molecular Entity
- Status: approved
Margenza 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 Margenza approved in United States?
Yes. FDA authorised it on 16 December 2020; FDA authorised it on 16 December 2020.
Who is the marketing authorisation holder for Margenza in United States?
MACROGENICS INC holds the US marketing authorisation.