National Center for Health Research president Diana Zuckerman defends FDA advisory committees, saying they do a more thorough job of evaluating produc...
Novo Nordisk reports favorable Phase 2 data for its investigational dual-action obesity and diabetes drug amycretin, showing significant reductions in...
A new study of FDA advisory committee meetings reveals that a substantial portion of public speakers support drug approval, and many have financial co...
FDA releases the form FDA-483 with six observations from an inspection at the Catalent Indiana sterile drug manufacturing facility in Bloomington, IN.
FDA cites PharmaTher over alleged misleading promotional claims for its generic ketamine.
Novo Nordisk says data from two global Phase 3 trials of semaglutide (Ozempic and Wegovy) have failed to slow clinical progression in adults with earl...
U.S. House and Senate health committee leaders express concern about a new FDA review pilot program because it appears designed to enable corruption a...
FDA investigators cite Molecular PharmaGroup, an outsourcing facility in New Providence, N.J., for multiple sterility and quality-control deficiencies...
