Posted by Michael Wonder on 19 Jan 2021
Biologics license application for narsoplimab in HSCT-TMA accepted for priority review by U.S. FDA
19 January 2021 - FDA sets PDUFA date of 17 July 2021.
Omeros Corporation announced today that the biologics license application for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy has been accepted for filing by the U.S. FDA.
The biologics license application has been granted priority review with an FDA action date of 17 July 2021 under the Prescription Drug User Fee Act. The FDA also indicated in its filing letter that the Agency is not currently planning to hold an advisory committee meeting to discuss the biologics license application.
