Omeros Corporation (OMER) Friday said it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for narsoplimab to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).
A decision from the regulator is expected in mid-2026.
The Biologics License Application (BLA) resubmitted for narsoplimab for the treatment of TA-TMA is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of September 25, 2025.
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Business News
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.