The American Clinical Laboratory Association and its fellow plaintiffs ask a Texas federal court to grant summary judgment in favor of its suit challe...
FDA warns Chula Vista, CA-based SoloVital it is marketing a misbranded and unapproved hyaluronic acid drug product as a dietary supplement.
The Department of Justice says Californian Paul Lamberty pleaded guilty in a Massachusetts federal court to conspiracy to defraud the United States an...
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).
