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).
FDA converts Mercks accelerated approval to full approval for its anti-PD-1 Keytruda (pembrolizumab) and its use in first-line treatment of advanced b...
Attorneys Anne Walsh and JP Ellison describe changes to two Justice Department policies on using guidance documents in enforcement actions.
FDA warns Turkeys Gulsah Uretim Kozmetik Sanayi Anonim Sirketi about CGMP violations in its production of finished drugs.