Posted by Michael Wonder on 02 Oct 2021
Omeros provides regulatory update on biologics license application for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy
1 October 2021 - Omeros Corporation today announced that the U.S. FDA notified the company that, as part of FDA’s on-going review of the company’s biologics license application for narsoplimab in the treatment of haematopoietic stem cell transplant-associated thrombotic microangiopathy, FDA has identified deficiencies that preclude discussion of labelling and post-marketing requirements/commitments at this time.
The FDA stated that the notification does not reflect a final decision on the information under review.
