FDA warns Chinas Shanwei Honghui Daily Appliance Co. about CGMP violations in its manufacturing of finished pharmaceuticals.
An FDA drug safety alert says Tesaros Varubi (rolapitant) injectable emulsion has been associated with anaphylaxis and other serious hypersensitivity ...
FDA releases its latest batch of Warning Letters that includes Becton Dickinson, Delta Laboratories, Schrofner Cosmetics, Shanwei Honghui Daily Applia...
The Justice Department says a second person has pleaded guilty to conspiring to market and distribute laser devices by falsely claiming they could cur...
FDA Review posts the Federal Register notices for the week ending 1/12/2018.
FDA Webviews newsroom closes Monday (1/15) in observance of Martin Luther King day.
FDA expands the approved use of AstraZenecas Lynparza (olaparib tablets) to include treating patients with certain types of breast cancer that have me...
Federal Register notice: FDA determines that the regulatory review period for Uromedicas Proact Adjustable Continence Therapy For Men was 3,892 days.