FDA clears a SamanTree Medical 510(k) for its Histolog Scanner for imaging the internal microstructure of tissues including identifying cells, vessels...
FDA approves Genentechs Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) twice-a-year subcutaneous injection for treating relapsing multiple sclero...
A group of bipartisan U.S. senators introduce the FDA Modernization Act 3.0, a bill to direct the agency to finally implement the FDA Modernization Ac...
FDA seeks comments on the use of its Integrated Review document as it decides to expand its use beyond new molecular entities, original BLAs, and sele...
Federal Register notice: FDA announces an 11/7 advisory committee meeting to review an IceCure Medical de novo request for its ProSense Cryoablation S...
FDA says it has added a Warning to labeling for Astellas Veozah about the risk of rare but serious liver injury.
A new National Academies book on collaboration in rare disease drug development lists steps it recommends that FDA take.
FDA publishes the eighth revision of a guidance on providing regulatory submissions for certain drug products in electronic format.
