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, CDC, and NIH announce an 11/25 public workshop entitled Live Biotherapeutic Products to Prevent Necrotizing Enterocoliti...
Two drug trade associations support an FDA approach to postapproval manufacturing changes in biosimilar and interchangeable biosimilar products.
FDA approves AstraZenecas Tagrisso for some non-small cell lung cancers.
