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FDA Medication Tracker

← All approvals · Immune & inflammatory · 2025

Yartemlea (narsoplimab-wuug)

The FDA approved Yartemlea (narsoplimab-wuug) on December 23, 2025 to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy.
Brand name
Yartemlea
Generic name
narsoplimab-wuug
FDA approval date
December 23, 2025
Approved use (FDA wording)
To treat hematopoietic stem cell transplant-associated thrombotic microangiopathy
Company
Omeros Corp
Application
BLA761152
Dosage form / route
INJECTION
Boxed warning on label
Not listed
Category on this site
Immune & inflammatory

Indications and usage, from the FDA label

YARTEMLEA is indicated for the treatment of adult and pediatric patients 2 years of age and older with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). YARTEMLEA is a MASP-2 inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.