Xortx says a meeting with FDA staff provided the information needed to initiate a Phase 3 study of its Xorlo to treat autosomal dominant polycystic ki...
FDA adds three new tools to the Catalog of Regulatory Science Tools to Help Assess New Medical Devices and updates listings for five existing tools.
FDA commissioner Robert Califf tells a Senate HELP hearing that FDA inspection, diagnostic devices, and supply chain transparency reforms are needed.
FDA and the Duke-Margolis Center for Health Policy announce a 6/7-8 public workshop on the agencys Rare Disease Endpoint Advancement Pilot Program.
Federal Register notice: FDA announces a 6/15 advisory committee to select strain(s) to be included in the Covid19 vaccines for the 20232024 season.
Federal Register notice: FDA creates a docket to receive public comments on the identification, assessment, and control of N-nitrosamine drug substanc...
FDA issues a complete response letter for Novo Nordisks concizumab, asking for additional dosing and manufacturing information.
FDA issues a warning on SD Biosensors Pilot Covid-19 At-Home Tests due to bacterial contamination concerns with its liquid solution.
