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.
Citrus Pharmaceuticals says it will submit a BLA to FDA later this year for its I/ONTAK T-cell lymphoma treatment.
FDA lifts its clinical hold on a Greenwich LifeSciences Phase 3 trial of the companys invasive breast cancer investigational treatment.
Catalyst says it has settled its patent litigation with Jacobus over Catalysts Firdapse and Jacobus Ruzurgi.