Posted by Michael Wonder on 08 Nov 2022
Omeros Corporation receives decision from FDA on formal dispute resolution request for narsoplimab
8 November 2022 - Decision denies Omeros’ appeal requesting immediate labeling discussions.
Omeros Corporation today announced that the Office of New Drugs of the US FDA has reached a decision on the company’s formal dispute resolution request appealing the issuance by FDA’s Office of Cardiology, Hematology, Endocrinology and Nephrology and the Division of Nonmalignant Hematology of a complete response letter concerning the biologics license application for narsoplimab in the treatment of haematopoietic stem cell transplant-associated thrombotic microangiopathy.
