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 ...
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...
