FDA — authorised 21 May 2021
- Application: BLA761210
- Marketing authorisation holder: JANSSEN BIOTECH
- Indication: Type 1 - New Molecular Entity
- Status: approved
🇺🇸 Rybrevant in United States
FDA authorised Rybrevant on 21 May 2021
Marketing authorisations
FDA — authorised 17 December 2025
- Application: BLA761433
- Marketing authorisation holder: JANSSEN BIOTECH
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
The FDA approved Rybrevant, a treatment for a specified indication, through a standard expedited pathway. The marketing authorisation was granted to Janssen Biotech, the marketing authorisation holder. This approval allows Janssen Biotech to market Rybrevant in the United States.
FDA — authorised 13 February 2026
- Application: BLA761484
- Marketing authorisation holder: JANSSEN BIOTECH
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
The US FDA approved Rybrevant, a product of Janssen Biotech, under the Type 5 indication for a new formulation or new manufacturer on 13 February 2026. This approval was granted through the standard expedited pathway. Rybrevant's marketing authorisation was assigned the application number BLA761484.
Rybrevant in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Rybrevant approved in United States?
Yes. FDA authorised it on 21 May 2021; FDA authorised it on 17 December 2025; FDA authorised it on 13 February 2026.
Who is the marketing authorisation holder for Rybrevant in United States?
JANSSEN BIOTECH holds the US marketing authorisation.