Federal Register notice: FDA announces a 9/18 Pediatric Advisory Committee meeting that will discuss post-marketing pediatric-focused safety reviews o...
FDA warns about adverse event reports it has received that may be related to overdoses due to dosing errors associated with compounded semaglutide inj...
FDA issues a clinical hold on a vTv Therapeutics Phase 3 trial (CATT1) involving cadisegliatin (XXX DE-ITALICIZE XXX)and its use in improving glycemic...
A new CDRH blog post outlines key activities that should be taking place during the lifecycle of artificial intelligence-enabled medical devices.
FDA clears a bioMrieux 510(k) for its Biofire Spotfire Respiratory/Sore Throat Panel Mini for detecting five of the most common viral and bacterial ca...
A January inspection of Brassica Pharmas Indian sterile drug manufacturing facility leads to a 10-observation Form FDA-483 that cites significant GMP ...
FDA grants fast-track designation to AC Immunes investigational candidate being developed with Janssen for Alzheimers disease.
FDA says Aurobindo has recalled one lot of its OTC Healthy Living migraine medication that was distributed through Amazon without the FDA-approved lab...
