FDA — authorised 17 December 2025
- Application: BLA761433
- Marketing authorisation holder: JANSSEN BIOTECH
- Local brand name: RYBREVANT FASPRO
- Indication: INJECTION
- Status: approved
🇺🇸 Amivantamab and Recombinant Human Hyaluronidase in United States
FDA authorised Amivantamab and Recombinant Human Hyaluronidase on 17 December 2025
Marketing authorisations
FDA — authorised 13 February 2026
- Application: BLA761484
- Marketing authorisation holder: JANSSEN BIOTECH
- Local brand name: RYBREVANT FASPRO
- Indication: VIAL — SINGLE-USE
- Status: approved
FDA
- Status: approved
Amivantamab and Recombinant Human Hyaluronidase in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Amivantamab and Recombinant Human Hyaluronidase approved in United States?
Yes. FDA authorised it on 17 December 2025; FDA authorised it on 13 February 2026; FDA has authorised it.
Who is the marketing authorisation holder for Amivantamab and Recombinant Human Hyaluronidase in United States?
JANSSEN BIOTECH holds the US marketing authorisation.