Qfitlia (fitusiran): a practical, evidence-based look at the newly approved hemophilia prophylaxis
Summary: On March 28, 2025 the U.S. FDA approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce bleeding in people 12 years and older with hemophilia A or B — with or without factor inhibitors. Qfitlia is an antithrombin-lowering, subcutaneously administered therapy that aims to restore thrombin generation rather than replacing missing clotting factors. […]
Article: FDA Issues New Guidance on Animal Studies for Dental Bone Grafting Materials
Background & Purpose On August 22, 2025, the FDA released its latest guidance titled “Animal Studies for Dental Bone Grafting Material Devices – Premarket Notification (510(k)) Submissions,” building upon the original Dental Bone Grafting Guidance from 2005 U.S. Food and Drug Administration+1. The document offers nonbinding recommendations on conducting animal studies for dental bone grafting […]