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BioWorld - Monday, March 23, 2026
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Home » FDA approves Omeros’ Yartemlea for stem cell patients
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FDA approves Omeros’ Yartemlea for stem cell patients

Dec. 24, 2025
By Lee Landenberger
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The U.S. FDA’s green lighting of Omeros Corp.’s Yartemlea (narsoplimab) makes it the first approved treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), a life-threatening complication of hematopoietic stem cell (HSC) transplantation. The BLA for narsoplimab, a fully human monoclonal antibody that inhibits the enzyme mannan-binding lectin-associated serine protease-2, had a Dec. 26 PDUFA date.
BioWorld Regulatory Immune Monoclonal antibody FDA

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