perform an assay that measures Factor VIII inhibitor concentration. Monitor plasma FVIII activity using a chromogenic assay or one-stage clotting assay. If one-stage clotting assay is used ...

with hemophilia A or B with or without factor VIII or IX inhibitors. The approval is based on data from the ATLAS phase 3 studies that demonstrated clinically meaningful bleed protection as measured ...

By targeting antithrombin, which can be reliably measured with an FDA-cleared blood assay, Qfitlia is ... A and B with and without factor VIII or IX inhibitors, and Breakthrough Therapy ...