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.
FDA says drug shortages remain a significant problem and it has identified two issues that need ongoing work to help address the situation.
Two Hyman, Phelps & McNamara attorneys say a recent case indicated there may be circumstances in which it is worth challenging in court FDAs position ...