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 authorisations
FDA
- Status: approved
DANYELZA in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is DANYELZA approved in United States?
Yes. FDA authorised it on 25 November 2020; FDA has authorised it.
Who is the marketing authorisation holder for DANYELZA in United States?
Y-MABS THERAPEUTICS INC holds the US marketing authorisation.