AuroMedics Pharma recalls two lots of piperacillin and tazobactam for injection, USP 3.375 g due to concerns that vials may contain particulate matter...
FDA approves a Shionogi NDA for Mulpleta (lusutrombopag), a once-daily, orally administered, small molecule thrombopoietin receptor agonist for treati...
Modulated Imaging has received FDA clearance for its Clarifi Imaging System, a diagnostic device that uses spatial frequency domain imaging to help cl...
FDA warns BioDiagnostics International about CGMP and other violations in its manufacturing of finished pharmaceuticals.
FDA grants Daiichi Sankyo a breakthrough therapy designation for quizartinib, an investigational FLT3 inhibitor for treating adult patients with relap...
FDA releases the FDA-483 with six observations from a Sharp Drugs inspection.
The New Civil Liberties Alliance asks FDA to adopt a rule that would require the agency to regulate only through notice-and-comment rulemaking.
FDA commissioner Scott Gottlieb says the agency is working on a new CVM five-year plan to advance antimicrobial stewardship in veterinary settings.