FDA removes information and documents regarding several diversity-related initiatives and policies, presumably in response to a Trump Administration E...
Former FDA associate commissioner for womens health Susan Wood passes away at her home in London after battling glioblastoma (brain cancer).
FDA says it is adding a Boxed Warning for anaphylaxis to the labeling for Tevas multiple sclerosis drug Copaxone and its Sandoz generic.
CBER director Peter Marks report for 2024 discusses Center approval of 67 products it says integrated advances in science and technology.
The U.S. Court of Federal Claims grants FDA summary judgment on the pleadings and rejects Vandas 5th Amendment taking argument about FDA disclosure of...
The union representing FDA employees sues President Trump over efforts to replace many Civil Service workers with political appointees.
The Trump Administration places a temporary embargo on external communications by FDA and other government health agencies until political appointees ...
FDA removes clinical hold on a Sanofi actual use trial to support its planned Rx-to-OTC switch for Cialis (tadalafil), which it licensed from Eli Lill...
