Federal Register notice: FDA clarifies that an executive summary of a public meeting on Testing Methods for Asbestos in Talc and Cosmetic Products Con...
FDA holds up an emergency use authorization for using blood plasma therapy for treating Covid-19 patients until more data is presented to demonstrate ...
FDA issues a complete response letter to Gilead for its filgotinib to treat rheumatoid arthritis, seeking information from two studies.
FDA issues a complete response letter for a Phase 3 trial of BioMarins gene therapy for severe hemophilia A.
FDA issues an immediately effective guidance to answer questions about some regulatory and policy issues during the Covid-19 public health emergency.
FDA clears an IlluminOss Medical 510(k) for its Photodynamic Bone Stabilization System for treating fibula fractures.
FDA clears a Hyperfine Research 510(k) to expand the use of its portable Swoop MRI imaging device to expand its brain imaging indication to include pa...