FDA — authorised 13 November 2025
- Application: BLA761450
- Marketing authorisation holder: SHANGHAI HENLIUS BIOTECH
- Local brand name: POHERDY
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
🇺🇸 POHERDY in United States
FDA authorised POHERDY on 13 November 2025
Marketing authorisations
FDA
- Status: approved
POHERDY 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 POHERDY approved in United States?
Yes. FDA authorised it on 13 November 2025; FDA has authorised it.
Who is the marketing authorisation holder for POHERDY in United States?
SHANGHAI HENLIUS BIOTECH holds the US marketing authorisation.