FDA approves an Eli Lilly BLA for Lyumjev (insulin lispro-aabc) injection, a new rapid-acting insulin indicated to improve glycemic control in adults ...
Endologix recalls the Ovation iX Abdominal Stent Graft System due to risks of liquid polymer leaks during implantation.
FDA releases its latest batch of Warning Letters that includes Cosmaceutical Research Lab, Fenwal International, Klarity Medical Products, and Takeda ...
FDA warns Takeda about CGMP violations at its drug manufacturing facility in Yamaguchi, Japan.
FDA makes available a guidance entitled Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.
Federal Register notice: FDA seeks comments on an information collection extension entitled Data To Support Drug Product Communications as Used by the...
Federal Register notice: FDA sends to OMB an information collection revision for Protection of Human Subjects and Institutional Review Boards; Certifi...
FDA warns Canadas Cosmaceutical Research Lab about CGMP and other violations in its production of finished drugs.