FDA clears a NinePoint Medical for the NvisionVLE Imaging System for use in the pancreas and bile duct.
The Government Accountability Office suggests ways in which FDA could address factors that restrict generic drug first review cycle approvals.
FDA accepts for priority review a Blueprint Medicines NDA for avapritinib for treating adult patients with PDGFRA Exon 18 mutant gastrointestinal stro...
FDA looks for potential vendors to perform whole heart simulations and studies.
Federal Register notice: FDA seeks interested industry organizations to participate in selecting a nonvoting industry representative to serve on CBER ...
Federal Register notice: FDA posts a list of seven information collections that have been recently approved by OMB.
FDA accepts an Alnylam Pharmaceuticals NDA for givosiran for treating acute hepatic porphyria.
FDA says its FY 2018 PMR/PMC performance report shows that the majority of post-marketing requirements and commitments were successfully completed or ...