FDA approves an Alpha Cognition NDA for ZUNVEYL (benzgalantamine) for treating mild-to-moderate Alzheimers disease.
FDA grants Elixir Medical a breakthrough device designation for its DynamX Sirolimus-Eluting Coronary Bioadaptor System for use in treating coronary a...
FDA extends by three months its review of a Syndax Pharmaceuticals NDA for revumenib and its use in treating adult and pediatric patients with relapse...
FDA approves Guardant Healths Shield blood test for colon cancer screening in adults 45 years of age and older who are at average risk for the disease...
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...
