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 ...
CDER reports on research into how healthcare providers view and use Boxed Warnings when making treatment decisions for their patients.
Denali Therapeutics plans to submit a BLA early next year that will seek accelerated approval for DNL310 (tividenofusp alfa) and its use in treating H...
FDA releases a guidance entitled Bioresearch Monitoring Technical Conformance Guide Technical Specifications Document that provides current agency sp...
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).
