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.
FDA issues a partial clinical hold on a BioNTech/Medilink Therapeutics Phase 1 clinical (NCT05653752) trial that is evaluating BNT326/YL202 in certain...
FDA approves Mercks Keytruda (pembrolizumab) for use with carboplatin and paclitaxel in adult patients with primary advanced or recurrent endometrial ...
Federal Register notice: FDA makes available a final guidance entitled Diabetic Foot Infections: Developing Drugs for Treatment.
FDA posts a final guidance entitled Facility Readiness: Goal Date Decisions Under GDUFA that provides information on how the agency intends to assign ...
FDA gives a one-item Form FDA-483 to Chugai Pharma Manufacturing Co. after inspecting the firms Utsunomiya, Tochigi, Japan facility 3/25 to 4/2.
