Attorney Jordan Thomas asks FDA to halt clinical trials of Cassava Sciences simufilam until the agency thoroughly evaluates the scientific support for...
Federal Register notice: FDA announces an 11/4 Psychopharmacologic Drugs Advisory Committee meeting to discuss a Levo Therapeutics NDA for Prader-Will...
FDA orders a drug class warning for Janus kinase inhibitors after reviewing a recent clinical trial that showed an increased risk of serious heart-rel...
FDA says it may approve returning ranitidine-containing products to the market based on new CDER research into the carcinogen NDMA.
FDA warns AnazaoHealth that it is compounding drugs that do not meet legal requirements and are considered to be misbranded unapproved new drugs.
Astellas pauses screening and dosing additional participants in its ASPIRO trial of an investigational gene therapy.
FDA acting commissioner Janet Woodcock weighs in on the announced departures of two senior CBER vaccine officials, pledging support and asserting conf...
FDA clears an Asensus Surgical 510(k) to expand the machine vision capabilities of its previously cleared Intelligent Surgical Unit (ISU).