FDA warns Stephen Fallon of Wilton Manors, FL, about bioresearch violations in his role as clinical investigator of a trial of an investigational prod...
FDA cautions Fenwal International about CGMP deviations at its Maricao, Puerto Rico, facility that manufactures blood pack units.
FDA grants Heartvue.ai a 510(k) clearance for its Heartvue.Proton, a machine learningpowered software for viewing, post-processing, and quantitative e...
FDA grants AstraZenenca an accelerated approval for Etcamah (camizestrant), an estrogen receptor antagonist, in combination with a CDK4/6 inhibitor (a...
There appears to be growing opposition to FDA commissioner nominee Heidi Overton, as a letter-writing campaign is underway to block her Senate confirm...
FDA approves Ionis Pharmaceuticals Zanvastro (zilganersen) injection for treating Alexander disease in pediatric and adult patients.
A Crowell & Moring analysis says FDA may increase regulatory scrutiny for user-facing GenAI-enabled devices.
FDA says helping to increase supplies of estradiol transdermal patches after reports that some patients are having difficulty finding their usual prod...
