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...
Federal Register notice: FDA seeks comments on an information collection extension on a requirement for submitting certain pediatric subpopulation dat...
Federal Register notice: FDA withdraws approval of 21 ANDAs from multiple applicants after they notified the agency that the drug products were no lon...
FDA orders Gynecology, Reproductive Endocrinology and Fertility Institute to immediately stop manufacturing cell/tissue products after an October insp...