Federal Register notice: FDA corrects a 3/9 notice that announced the withdrawal of approval of 16 ANDAs abbreviated from multiple applicants.
FDA warns four manufacturers of unapproved injectable drugs labeled as homeopathic.
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 ...