The New York Times reports that ongoing turmoil at FDA has increasingly placed commissioner Marty Makary under the microscope, raising concerns among ...
FDA cites a GlaxoSmithKline biologicals manufacturing site in Hungary for significant lapses in deviation investigations and material controls, includ...
FDA posts two separate Form 483 inspection reports citing a range of quality and compliance deficiencies at Catalent Maryland, Inc., highlighting ongo...
A new FDA safety update says safety risks associated with AstraZenecas Andexxa outweigh the drugs benefits, leading the agency to ask the company to p...
FDA cites SCA Pharmaceuticals for multiple deficiencies in sterile drug manufacturing practices following a 10-day inspection of the companys facility...
The CDER Office of Prescription Drug Promotion says a TV spot for Karuna Therapeutics Cobenfy is false or misleading in its description of the drugs u...
FDA releases the form FDA-483 with five observations from a recent inspection of the UBI Pharma drug manufacturing facility in Hsinchu, Taiwan.
A new study shows that Eli Lillys investigational oral obesity drug helped patients largely maintain weight loss after transitioning off injectable in...
