FDA clears an Anumana 510(k) for an artificial intelligencebased tool designed to detect early signs of pulmonary hypertension.
FDA posts a Form 483 that identifies deficiencies in quality system procedures at a manufacturing facility operated by CSL Behring GmbH in Marburg, Ge...
FDAs new draft guidance outlining expectations for how drug manufacturers should respond to Form FDA 483 observations following inspections of current...
FDA commissioner Marty Makary shares his expansive vision for future medical breakthroughs, telling agency staff he hopes to see transformative treatm...
FDA says beginning 10/1 it will require drugmakers and other regulated entities to adopt updated international data standards for submitting postmarke...
FDA grants Context Therapeutics a fast-track designation for its experimental therapy CTIM-76 for treating platinum-resistant ovarian cancer.
HHS is considering reversing a 2023 FDA decision that deemed a group of peptide drugs too risky for use by compounding pharmacies, a move that has spa...
FDA denies a petition seeking a partial exemption of 510(k) requirements for some specific radiology computer-aided detection and/or diagnosis devices...
