FDA — authorised 18 December 2025
- Application: BLA761473
- Marketing authorisation holder: FORMYCON AG
- Local brand name: NUFYMCO
- Indication: INJECTION
- Status: approved
🇺🇸 NUFYMCO in United States
FDA authorised NUFYMCO on 18 December 2025
Marketing authorisations
FDA
- Status: approved
NUFYMCO in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is NUFYMCO approved in United States?
Yes. FDA authorised it on 18 December 2025; FDA has authorised it.
Who is the marketing authorisation holder for NUFYMCO in United States?
FORMYCON AG holds the US marketing authorisation.