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...
Johnson & Johnson discontinues its Auτonomy Phase 2b Alzheimers study after interim data showed its experimental antibody posdinemab failed to pr...
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...
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.
FDA cites PharmaTher over alleged misleading promotional claims for its generic ketamine.
Three Harvard medical professors raise concerns over FDAs review voucher program that they say could politicize drug approvals and undermine scientifi...
FDA posts a Federal Register notice finalizing the withdrawal of Intercept Pharmaceuticals Ocaliva (obeticholic acid) from the U.S. market for treatin...
