A January inspection of Brassica Pharmas Indian sterile drug manufacturing facility leads to a 10-observation Form FDA-483 that cites significant GMP ...
FDA approves a Sun Pharmaceutical Industries NDA for Leqselvi (deuruxolitinib) 8 mg tablets for treating adults with severe alopecia areata.
Federal Register notice: FDA announces the renewal for two years of its Pulmonary-Allergy Drugs Advisory Committee.
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...
