Posted by Michael Wonder on 06 May 2025
FDA accepts resubmission of BLA for narsoplimab for haematopoietic stem cell transplant-associated thrombotic microangiopathy and assigns late September PDUFA date
6 May 2025 - Omeros Corporation today announced that the US FDA has accepted for review the resubmission of the biologics license application for narsoplimab for the treatment of haematopoietic stem cell transplant-associated thrombotic microangiopathy.
The resubmission was classified as a Class 2 resubmission and pursuant to the PDUFA has been assigned a target action date for the FDA decision in late September 2025.
