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...
FDA issues an early alert warning about a potentially high-risk defect in certain Fresenius Kabi Ivenix large volume pump primary administration sets.
Johnson & Johnson discontinues its Auτonomy Phase 2b Alzheimers study after interim data showed its experimental antibody posdinemab failed to pr...
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...
Former FDA principal deputy commissioner Janet Woodcock and policy experts from Duke University call on the agency to adopt new tools and pathways to ...
FDA investigates the death of a pediatric patient with congenital thrombotic thrombocytopenic purpura who developed neutralizing antibodies to the enz...
