🇺🇸 Emrelis in United States

FDA authorised Emrelis on 14 May 2025

Marketing authorisations

FDA — authorised 14 May 2025

Application: BLA761384
Marketing authorisation holder: ABBVIE INC
Local brand name: EMRELIS
Indication: VIAL — SINGLE-DOSE
Status: approved

The FDA approved Emrelis, a new molecular entity, on 14 May 2025, under the standard expedited pathway. The marketing authorisation holder is ABBVIE INC. The approval was granted for the treatment of a specific condition, but the exact indication is not specified in the available data. Further information on the approved indication and local brand name is not reported.

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FDA

Marketing authorisation holder: ABBVIE INC
Status: approved

Emrelis 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 Emrelis approved in United States?

Yes. FDA authorised it on 14 May 2025; FDA has authorised it.

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

ABBVIE INC holds the US marketing authorisation.