FDA proposes to deny a Vanda NDA for tradipitant and offers the company an opportunity to seek a commissioners hearing on the denial.
FDA accepts for review a Johnson & Johnson NDA for TAR-200 (gemcitabine), an intravesical drug releasing system for treating certain patients with Bac...
FDA warns Integra Lifesciences about Quality System Regulation violations in the manufacturing of neurological and neurosurgical medical devices at th...
FDA warns Marlborough, MA-based Hologic about Quality System and Medical Device Reporting violations in its production of implantable radiographic mar...
Federal Register notice: FDA issues Novo Nordisk a priority review voucher for gaining approval for its hemophilia drug Alhemo (concizumab-mtci) last ...
Federal Register notice: FDA withdraws the approval of 12 NDAs from multiple applicants because they are no longer marketed.
The HHS Inspector General raises concerns about three of 24 drugs approved through the FDA accelerated approval pathway.
FDA says a new method of determining an acceptable intake limit for nitrosamine impurities in drugs that it helped to develop has expedited regulatory...
