FDA grants accelerated approval to Mercks Keytruda (pembrolizumab) for treating certain patients with recurrent locally advanced or metastatic gastric...
FDA has approved magnetic resonance-conditional labeling for Abbotts Ellipse implantable cardioverter defibrillator and associated pacing leads.
FDA issues Janssen Biotech a complete response letter on a BLA for sirukumab and its use in treating moderately to severely active rheumatoid arthriti...
Federal Register notice: FDA makes available a draft guidance entitled Statistical Approaches to Evaluate Analytical Similarity.
Aegerion Pharmaceuticals agrees to plead guilty in the Massachusetts federal court to two misdemeanor misbranding charges involving Juxtapid (lomitapi...
Public Citizen asks the DC federal court to compel FDA to act on the advocacy groups petition asking that benzocaine not be permitted in infant teethi...
Attorney Mark DuVal faults what he sees as FDAs new, less collaborative approach to determining whether a 510(k) is substantially equivalent to its pr...
FDA clears a ClaroNav 510(K) for NaviENT, a computer-assisted surgical navigation system for surgical procedures inside a patients skull.