FDA clears a Diazyme Laboratories 510(k) to market its EZ Vitamin D Assay for clinical chemistry analyzers.
FDA clears a Medrobotics Corp. 510(k) for expanding the use of the Flex Robotic System for robot-assisted visualization in general surgical, gynecolog...
To address ongoing critical product shortages, FDA approves shelf life extensions on certain Baxter Healthcare intravenous solutions that are in short...
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Ardea Biosciences Zurampic (lesinurad) was...
FDA grants Janssen a priority review for its supplemental BLA to use Darzalex (daratumumab) in combination with bortezomib, melphalan and prednisone f...
FDA sends South Korea-based Daewoong Pharmaceutical a 10-item Form 483 after an 11/2017 inspection found significant GMP violations at the drug substa...
FDA clears a Surmodics 510(k) for its Telemark .014 inch coronary and peripheral support microcatheter, intended for use in complex coronary and perip...