FDA — authorised 25 November 2020
- Application: BLA761171
- Marketing authorisation holder: Y-MABS THERAPEUTICS INC
- Local brand name: DANYELZA
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 DANYELZA in United States
FDA authorised DANYELZA on 25 November 2020
Marketing authorisation
Other Oncology approved in United States
Frequently asked questions
Is DANYELZA approved in United States?
Yes. FDA authorised it on 25 November 2020.
Who is the marketing authorisation holder for DANYELZA in United States?
Y-MABS THERAPEUTICS INC holds the US marketing authorisation.