The U.S. Food and Drug Administration approved Omeros Corp.’s Yartemlea (narsoplimab) as the first indicated therapy for hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA). The approval establishes a regulatory option for a life‑threatening complication of hematopoietic stem cell transplantation that previously lacked approved targeted treatments. Omeros’ green light is expected to change treatment algorithms in transplant centers treating TA‑TMA and will trigger formulary and reimbursement negotiations as hospitals adapt care pathways. The FDA decision follows Omeros’ clinical package showing benefit in the TA‑TMA patient population and will likely prompt post‑approval safety monitoring given the vulnerable patient cohort.