FDA clears a Masimo 510(k) for the RD SET sensors with Masimo Measure-through Motion and Low Perfusion SET pulse oximetry that is intended to provide ...
Federal Register notice: FDA awards a priority review voucher to Leadiant Bioscience after determining that rare disease drug Revcovi (elapegademase-l...
The Council on Economic Advisors says FDA efforts to control drug prices are providing savings to consumers.
FDA publishes a draft guidance on legal requirements for drug supply chain verification systems.
FDA approves an updated label for Novo Nordisks Saxenda to add cardiovascular risk data for the drugs active ingredient from the LEADER trial of a dif...
FDA issues a white paper outlining issues to be discussed at a December workshop on the distinctions between medical device servicing and remanufactur...
FDA clears a Rocky Mountain Orthodontics 510(k) for Orthocaps, a transparent and removable appliance for correcting tooth malpositions.
Pfizer and Lilly say a Phase 3 trial of their novel osteoarthritis monoclonal antibody met all three co-primary efficacy endpoints.