FDA says the American Contract Systems recall of two test kits is Class 1.
FDA commissioner Robert Califf says his tenure at FDA will focus on improving evidence generation, which he described as being mediocre, and on tackli...
The heads of FDA and the U.S. Patent and Trademark Office describe joint actions they are taking to lower drug prices and boost competition.
FDA accepts a PMA module from Empirical Spine for its LimiFlex Dynamic Sagittal Tether, a spinal implant for grade 1 degenerative spondylolisthesis pa...
FDA grants de novo marketing authorization for two Apollo Endosurgery endoscopic systems used in obese patients.
FDA grants an emergency use authorization for Novavaxs Covid-19 Vaccine, Adjuvanted for preventing disease caused by severe acute respiratory syndrome...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for AbbVies Rinvoq (upadacitinib).
FDA clears the Philips SmartSpeed MR acceleration software.