FDA commissioner Marty Makarys resignation capped one of the shortest and most turbulent FDA tenures in recent memory, with media reports over the pas...
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...
Americans for Scientific Integrity asks FDA to add reproductive development warnings and use instructions to labeling for over-the-counter acetaminoph...
A citizen petition urges FDA to take enforcement action against the BariClip, an implantable bariatric device that petitioners say is being marketed a...
FDA says Sun Pharma has recalled one batch of doxorubicin HCl liposome injection due to glass particles found in some vials during production.
CDER publishes a Manual of Policies and Procedures on approaches for assessing drug substance and drug product impurity acceptance criteria for non-mu...
AstraZeneca reports positive data in a trial evaluating perioperative treatment with Imfinzi (durvalumab) combined with neoadjuvant enfortumab vedotin...
FDA posts a draft guidance outlining recommendations for drugmakers developing local anesthetic products designed to provide prolonged postoperative p...
