FDA declines to appear before the House Energy and Commerce Oversight and Investigations Subcommittee as it holds a critical hearing on the agencys fo...
Percussionaire recalls its High Frequency Transport Phasitron Breathing Circuit Kits due to a product defect that causes over-pressurization.
Valneva says it has sold an FDA tropical disease priority review voucher for $103 million that it will use to fund research and development efforts.
FDA approves a 50% pain reduction indication for Boston Scientifics WaveWriter Spinal Cord Stimulator in treating chronic low back and leg pain.
Federal Register notice: FDA makes available a final guidance entitled Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3...
Bloomberg News reports that FDA inspectors found problems at a Catalent Indiana facility that is being bought by Novo Nordisk to expand the supply of ...
FDA approves a Veru IND to begin a Phase 2b clinical study to evaluate enobosarm and its use in preserving muscle mass and physical function and incre...
Insight Pharmaceuticals recalls two lots of its TING 1% Tolnaftate Athletes Foot Spray Antifungal Spray Liquid due to elevated benzene levels.