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.
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...
The U.S. House of Representatives passes the Give Kids a Chance Act (HR 3433) that is intended to address childhood cancer and rare diseases.
