FDA clears a Hologic 510(k) for its Panther Fusion Paraflu assay, a multiplexed assay which runs on the new Panther Fusion system.
A Massachusetts federal jury says a New England Compounding Center pharmacist is guilty of racketeering and fraud, but not of second-degree murder in ...
FDA releases a video series for industry on the 2017 GDUFA reauthorizations new features.
Follea says it has submitted to FDA a de novo application for its Minoxidil Response Test.
President Trump declares the opioid abuse crisis in the U.S. to be a public health emergency while briefly mentioning FDAs role in the effort.
FDA accepts for review a Genentech supplemental BLA for Avastin (bevacizumab) for its use in combination with chemotherapy, followed by Avastin alone,...
Federal Register notice: FDA makes available a draft guidance entitled Breakthrough Devices Program; Draft Guidance for Industry and Food and Drug Adm...
FDAs Los Angeles District issues a nine-page Warning Letter to an OTC drug manufacturer that allegedly makes topical pain drugs in the kitchen of a ho...