Yartemlea (narsoplimab-wuug)

New biologicPriority review

Region: 🇺🇸 US
Active substance: narsoplimab-wuug
Company: Omeros Corp
Status: Approved
FDA approval: Tue 23 Dec 2025
Designations: New biologic, Priority review
Application: BLA761152
Official record: www.accessdata.fda.gov

Regulatory milestones

Thu 15 Oct 2026🇪🇺 CHMP negative opinion

Yartemlea (Narsoplimab): CHMP negative opinion

Omeros Ireland Limited · source

Tue 23 Dec 2025🇺🇸 FDA approval

FDA approves Yartemlea (narsoplimab-wuug), a new medicine

Omeros Corp; BLA761152; New biologic, Priority review; injection · source

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.