The FDA Oncology Drugs Advisory Committee votes not to recommend using immune checkpoint inhibitors in first-line advanced gastric cancer with PD-L1 e...
Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Device Recall Authority.
Merck says a trial assessing favezelimab and Keytruda (pembrolizumab) failed to meet its primary endpoint in patients with previously treated PD-L1 po...
FDA posts forms FDA-483 issued following inspections at Samsung Bioepis in Incheon, Republic of Korea, and Terumo Yamaguchi in Yamaguchi, Japan.
Two House Democrat lawmakers ask the HHS Office of Inspector General to investigate potential conflict-of-interest appearances raised in last months N...
Media reports indicate that FDA and Customs and Border Protection intercepted $270,000 worth of counterfeit and unapproved weight loss drugs in Cincin...
FDA clears a Piur Imaging 510(k) for the Piur tUS Infinity that transforms existing 2D ultrasound devices into advanced 3D imaging systems for thyroid...
Lilly asks an Indiana federal court to overturn an FDA determination that the companys retatrutide is a drug rather than a biologic.
