AstraZeneca reports positive results from two trials evaluating new breast cancer treatments.
Federal Register notice: FDA launches a Rare Disease Endpoint Advancement Pilot Meeting Program.
FDA posts eight generic drug research priority initiatives for FY 2023.
FDA says Baxter International has issued an urgent medical device correction for its WatchCare incontinence system that may cause radio interference w...
FDA publishes a guidance to help agency staff request additional information needed to make decisions on medical device marketing applications.
The Medical Device Innovation Consortium releases its first medical device manufacturer benchmark report on cybersecurity maturity.
FDA commissioner Robert Califf says he hopes Congress will include regulation of laboratory-developed tests and several other issues in a December fun...
FDA postpones an 11/18 joint advisory committee that was going to vote on a Laboratoire HRA Pharma supplemental NDA for Opill (norgestrel, 0.075 mg), ...
