FDA Accepts Narsoplimab BLA Resubmission for Transplant-Associated TMA

FDA Accepts Narsoplimab BLA Resubmission for Transplant-Associated TMA

The resubmitted biologics license application for narsoplimab in transplant-associated thrombotic microangiopathy has been accepted by the FDA.

FDA accepts Omeros’ BLA resubmission for narsoplimab in TA-TMA - BioTuesdays

Omeros Corporation (NASDAQ:OMER) announced that the FDA will review its resubmission of the Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). According to the company, the resubmission was classified as a Class 2 and pursuant to the Prescription Drug User Fee Act has been assigned an FDA decision target date in late September 2025. The BLA r…

FDA Accepts Resubmission of BLA for Narsoplimab for Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy (TA-TMA) and Assigns Late September PDUFA Date

SEATTLE–(BUSINESS WIRE)–Omeros Corporation (Nasdaq: OMER) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). The resubmission was classified as a Class 2 resubmission and pursuant to the Prescription Drug User Fee Act (PDUFA) has b…