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...
FDA posts a draft guidance outlining recommendations for drugmakers developing local anesthetic products designed to provide prolonged postoperative p...
Three Morgan Lewis attorneys say companies regulated by FDA should prepare for increased scrutiny due to near-real-time data being available in the ag...
FDA publishes draft guidances on developing non-opioid analgesics for chronic pain and facilitating a benefit/risk analysis for opioid analgesics.
A CDER Office of Prescription Drug Promotion Notice of Violation cites a misleading BeOne Medicine TV spot for its leukemia drug Brukinsa.
