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...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for GlaxoSmithKlines Ojjaara (momelotinib).
Two stakeholders say it is important that FDA state that principles in a question-and-answer guidance on pre-approval manufacturing changes to biosimi...
