Academic researchers say all 34 low molecular weight, protein-targeted, antineoplastic agents approved by FDA between 2019 and 2023 were facilitated i...
AstraZeneca says its CAPItello-290 Phase 3 trial of Truqap (capivasertib) in combination with paclitaxel in patients with locally advanced or metastat...
FDA Webviews newsroom closes Wednesday 6/19 in recognition of the federal holiday Juneteenth.
Federal Register notice: FDA issues a final rule revising its requirements for current good manufacturing practice, postmarketing safety reporting, an...
FDA places a partial clinical hold on three Zentalis Pharmaceuticals azenosertib studies after two recent deaths due to presumed sepsis were reported....
FDA grants Elixir Medical a Breakthrough Device Designation for its novel bioadaptive implant DynamX Sirolimus-Eluting Coronary Bioadaptor System for ...
FDA grants Merck accelerated approval for Capvaxive (Pneumococcal 21-valent conjugate vaccine) for preventing invasive disease and pneumonia caused by...
FDA clears an Akili 510(k) for EndeavorOTC (AKL-T01) as an over-the-counter treatment for adults with attention-deficit/hyperactivity disorder.
