FDA approves an updated dosing schedule for Eli Lillys Alzheimers therapy Kisunla (donanemab-azbt) to reduce the risk of a known side effect called am...
FDA warns Vineyard, UT-based Dynamic Blending Specialists about multiple violations in its work as a contract manufacturer of over-the-counter drug pr...
FDA warns Berkeley, CA-based Libby Laboratories about CGMP violations in its manufacturing of finished drugs.
University of Illinois law school scholar Sara Gerke calls for FDA to create AI Facts labeling for artificial intelligence-powered medical devices.
A Foundation for Defense of Democracies paper calls on FDA to correct a gap in a recent guidance that makes in-use medical devices vulnerable to cyber...
A letter from dozens of biotechnology industry executives and investors urges FDA commissioner Marty Makary to reject efforts to restrict access to th...
FDA drops REMS requirements covering embryofetal toxicity risk in endothelin receptor antagonists.
FDA warns Lenoir, NC-based Exela Pharma Sciences about CGMP violations in its work as a drug manufacturing outsourcing facility.
