Bristol Myers Squibb (BMS) and Johnson & Johnson stop their Phase 3 Librexia ACS trial of the investigational anticoagulant milvexian after an indepen...
FDA commissioner Marty Makary and CBER director Vinay Prasad preview upcoming agency reforms during an FDA Direct podcast focused on the appointment o...
An Axios report examines growing criticism of recent FDA actions that are fueling uncertainty among drug developers and weakening public confidence in...
The ACLU files a lawsuit seeking to force FDA to release documents related to its ongoing safety review of mifepristone.
FDA says it is approving new labeling submitted by Sarepta Therapeutics for its gene therapy Elevidys (delandistrogene moxeparvovec-rokl) that include...
FDA grants Parabilis Medicines a fast track designation for FOG-001, a first-in-class inhibitor targeting the β-catenin:TCF interaction, for trea...
FDA posts a final guidance entitled Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, ...
Gilead Sciences says its investigational single-tablet regimen combining bictegravir and lenacapavir met its primary endpoint in a pivotal Phase 3 tri...
