FDA clears an AliveCor 510(k) to use its KardiaMobile 6L device to calculate patients QTc interval.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Beovu (brolucizumab-dbll), indicated for treati...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Acacia Pharmas Barhemsys (amisulpride), indicat...
Federal Register notice: FDA posts a final guidance entitled Unique Device Identification System: Form and Content of the Unique Device Identifier.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Pulmonx Corp.s Zephyr Endobronchial Valve Impla...
Rep. Katie Porter calls for an HHS inspector general probe of drug company influence on FDA drug evaluations and approvals.
Responding to a complete response letter, Athenex says it is working on a new clinical trial of oral paclitaxel and encequidar to treat metastatic bre...
FDA grants Hyalex Orthopedics a breakthrough device designation for the Hyalex Cartilage System, intended for use in repairing cartilage defects.