Pfizer CEO Albert Bourla tells TD Cowen healthcare conference that the leadership of FDAs biologics center is worrisome because it disregards the reco...
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 recommends that uniQure conduct a randomized, double-blind, sham surgery-controlled trial before seeking BLA approval for its Huntingtons disease ...
Merck says that adding Welireg (belzutifan) to Keytruda as adjuvant therapy significantly reduced the risk of disease recurrence or death in certain p...
FDA accepts for priority review a Takeda and Protagonist Therapeutics NDA for rusfertide, positioning the drug as a potential first-in-class treatment...
FDA approves a Synergy Spine Solutions PMA for its Synergy Disc, a motion-preserving artificial cervical disc.
