FDA approves Genentechs Tecentriq (atezolizumab) and a subcutaneous formulation of the drug for the adjuvant treatment of certain patients with muscle...
FDA says Sun Pharma has recalled one batch of doxorubicin HCl liposome injection due to glass particles found in some vials during production.
University of Missouri law professor Erika Lietzan says FDA may not suffer as much under the Supreme Courts Loper Bright decision as policy analysts f...
CDER publishes a Manual of Policies and Procedures on approaches for assessing drug substance and drug product impurity acceptance criteria for non-mu...
FDA commissioner Marty Makarys resignation capped one of the shortest and most turbulent FDA tenures in recent memory, with media reports over the pas...
AstraZeneca reports positive data in a trial evaluating perioperative treatment with Imfinzi (durvalumab) combined with neoadjuvant enfortumab vedotin...
A citizen petition urges FDA to take enforcement action against the BariClip, an implantable bariatric device that petitioners say is being marketed a...
Americans for Scientific Integrity asks FDA to add reproductive development warnings and use instructions to labeling for over-the-counter acetaminoph...
