The FDA approved Omeros Corporation’s Yartemlea (narsoplimab), making it the first approved therapy for hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA). The approval completed a Dec. 26 PDUFA and grants a regulatory pathway for a previously unmet post‑transplant complication. Omeros will now move toward commercialization and implementation in transplant centers; clinicians and payers will focus on label language, real‑world safety monitoring, and access strategies given the small but high‑severity patient population.