Vanda Pharmaceuticals sues FDA, seeking an advisory committee meeting to assess the companys pending NDA for tradipitant and its use in treating sympt...
FDA clears a Zynex 510(k) for its TensWave, a transcutaneous electrical nerve stimulation therapy for reducing chronic and acute pain.
FDA clears a Ventis Medical 510(k) for the VM-2000, an emergency transport ventilator that allows medical personnel to provide respiratory support in ...
Federal Register notice: FDA revokes a 2020 emergency use authorization granted to Roche Molecular Systems for the cobas SARS-CoV2 & Influenza A/B nuc...
Federal Register notice: FDA classifies intervertebral body graft containment devices into Class 2 (special controls).
FDA warns Atlanta, GA-based physician Julio Flamini about concerns related to investigations at his Clinical Integrative Research Center of Atlanta.
FDA warns Coral Gables, FL-based Mother Stem Institute about illegally marketing stromal vascular fraction products derived from donor adipose tissue ...
PhRMA makes nine recommendations for changes to an FDA draft guidance on the platform technology designation program.
