Posted by Michael Wonder on 14 Nov 2020
FDA issues complete response letter for sutimlimab, an investigational treatment for haemolysis in adults with cold agglutinin disease
14 November 2020 - Complete response letter refers to deficiencies from a pre-license inspection of a third-party manufacturing facility.
The U.S. FDA issued a complete response letter regarding the biologics license application for sutimlimab, an investigational monoclonal antibody for the treatment of haemolysis in adults with cold agglutinin disease.
