The 3rd Circuit Court of Appeals asks a New Jersey federal court to look at hundreds of Fosamax bone fracture cases and determine whether they are pre...
FDA clears a NeuroOne Medical Technologies 510(k) to market its thin film cortical electrode technology for temporary (less than 30 days) recording, m...
Immunomedics resubmits its BLA seeking accelerated approval for sacituzumab govitecan, indicated for treating certain patients with metastatic triple-...
FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), Mercks anti-PD-1 therapy as monotherapy for treating patients w...
FDAs Office of New Drugs denies a Lexicon Pharmaceuticals appeal of a March Complete Response Letter on its NDA for diabetes drug Zynquista (sotaglifl...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Ultragenyxs Crysvita.
FDA releases a final guidance entitled Adaptive Designs for Clinical Trials of Drugs and Biologics.
FDA says that most recent, interim post-approval study results for the Impella RP System continue to show a favorable survival rate compared with pre...