CBER director Peter Marks gets high grades from former FDA commissioner and Biden administration Covid chief science officer David Kessler on Marks le...
Johns Hopkins University researchers say spending on direct-to-consumer ads in 2020 was associated with drugs rated with lower added clinical benefit ...
The DC District Court dismisses for lack of standing a Pharmaceutical Research and Manufacturers of America-led lawsuit that sought to block HHS and F...
A Roche Phase 3 study called COMMODORE 2 that was evaluating the efficacy and safety of crovalimab in certain people with paroxysmal nocturnal hemoglo...
FDA proposes an advisory committee-led hearing to address a CDER 2021 decision not to approve an NDA submitted by Intarcia Therapeutics for ITCA 650 (...
FDA warns Alajuela, Costa Rica-based MicroVention Costa Rica about Quality System regulation violations in the manufacture of microcatheters and ballo...
FDA warns Nendingen, Germany-based Getsch+Hiller Medizintechnik about Quality System violations in its production of adulterated and misbranded monopo...
Federal Register notice: FDA seeks comments on an information collection extension entitled FDA Administrative Practices and Procedures; Formal Hearin...
