FDA warns Fenwal International about CGMP deviations in manufacturing the firms blood-pack units with and without in-line leukoreduction filters, as w...
The DC Appeals Court affirms the DC federal courts rejection of an HHS rule requiring drug companies to include the wholesale acquisition price of som...
FDA says it approved Jazz Pharmas Zepzelca for treating some small cell lung cancer cases.
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.