A new JAMA research article finds that between 2018 and 2021, FDA approved 210 new drugs and 21 (10.0%) were approved based on pivotal studies with nu...
FDA Inspection findings at Indias Biocon Biologics lead to a complete response letter on its BLA for a biosimilar version of bevacizumab (Genentechs A...
An FDA inspection of Indias Laurus Labs results in a Form 483 with two undisclosed observations.
Johnson & Johnsons Ethicon unit agrees to a $10 million settlement with Kentucky over alleged deceptive marketing practices involving the companys pel...
FDA posts a draft guidance entitled Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development.
An FDA advisory committee votes 8 to 5 that GlaxoSmithKlines proposals for two single-arm clinical trials of its Jemperli (dostarlimab) are sufficient...
FDA commissioner Robert Califf tells an Alliance for a Stronger FDA fireside chat that while new artificial intelligence advances are quickly becoming...
FDA issues an emergency use authorization for the Cepheid Xpert Mpox test for use in a point-of-care setting for detecting monkeypox.
