🇺🇸 Imaavy in United States

FDA authorised Imaavy on 29 April 2025

Marketing authorisations

FDA — authorised 29 April 2025

Application: BLA761430
Marketing authorisation holder: JANSSEN BIOTECH
Local brand name: IMAAVY
Indication: INJECTABLE — INJECTION
Status: approved

The FDA approved Imaavy, a new molecular entity, on 29 April 2025. The marketing authorisation was granted to JANSSEN BIOTECH under standard expedited pathway. The approval was based on a new molecular entity application number BLA761430.

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FDA

Marketing authorisation holder: JANSSEN BIOTECH
Status: approved

Imaavy in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Immunology approved in United States

Frequently asked questions

Is Imaavy approved in United States?

Yes. FDA authorised it on 29 April 2025; FDA has authorised it.

Who is the marketing authorisation holder for Imaavy in United States?

JANSSEN BIOTECH holds the US marketing authorisation.