FDA issues a letter to healthcare providers warning about the potential risk of early structural valve deterioration with Abbott Trifecta heart valves...
FDA proposes that Pfizer include Guillain-Barr syndrome and other immune-mediated demyelinating conditions in a pharmacovigilance plan if the companys...
Federal Register notice: FDA posts a draft guidance entitled Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment.
FDA accepts for review a Verrica Pharmaceuticals NDA resubmission for VP-102 to treat molluscum contagiosum, described by the Centers for Disease Cont...
FDA issues a five-year debarment order against former Indivior CEO Shaun Thaxter based on an earlier misdemeanor conviction.
FDA accepts for priority review a SpringWorks Therapeutics NDA for nirogacestat, an investigational gamma secretase inhibitor for treating adults with...
CDER promotes Office of Compliance deputy director Jill Furman as permanent director after serving as acting director since previous head Don Ashley r...
FDA issues Lucira an emergency use authorization for the first over-the-counter at-home diagnostic test for detecting influenza A and B, and Covid-19.
