FDA removes a clinical hold against Intellia Therapeutics and its MAGNITUDE Phase 3 trial of nexiguran ziclumeran (nex-z), an experimental CRISPR-base...
Three former senior FDA officials tell a federal appeals court that the Trump administration mischaracterized the science on contraceptive safety when...
HHS directs FDA and other health agency employees to immediately stop using the artificial intelligence platform Claude after the Trump administration...
FDA approves a Synergy Spine Solutions PMA for its Synergy Disc, a motion-preserving artificial cervical disc.
A leading myeloma researcher says FDAs draft guidance endorsing minimal residual disease as a potential basis for accelerated drug approvals in multip...
Drug user fee negotiators confront lingering divisions over FDAs America First proposals and the structure of hiring commitments, according to just-po...
The U.S. Department of Justice (DoJ) says a Federal Circuit ruling on so-called generic drug skinny labels threatens to undermine the Hatch-Waxman fra...
Rare disease drug developers and patient advocates are applauding a series of new guidance documents from FDA that bring long-awaited clarity to regul...
