🇺🇸 Yartemlea in United States

FDA authorised Yartemlea on 23 December 2025

Marketing authorisations

FDA — authorised 23 December 2025

Application: BLA761152
Marketing authorisation holder: OMEROS CORP
Indication: Type 1 - New Molecular Entity
Status: approved

The FDA approved Yartemlea, a new molecular entity, for marketing in the United States. The approval was granted to OMEROS CORP, the marketing authorisation holder, on 23 December 2025. The application number for this approval is BLA761152.

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FDA

Marketing authorisation holder: OMEROS CORP
Status: approved

Yartemlea 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 Yartemlea approved in United States?

Yes. FDA authorised it on 23 December 2025; FDA has authorised it.

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

OMEROS CORP holds the US marketing authorisation.