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.
Federal Register notice: FDA revokes 15 Emergency Use Authorizations on 12 decontamination systems for personal protective equipment, one bioburden re...
Two senior CBER vaccine officials announce they are leaving FDA over the next couple of months untimely departures that signal trouble with how the a...