FDA accepts for review a Kyowa Hakko Kirin resubmitted NDA for KW-6002 (istradefylline), an investigational selective adenosine A2A receptor antagonis...
FDA extends by three months the review of a Daiichi Sankyo NDA for quizartinib, an investigational FLT3 inhibitor currently under priority review for ...
Federal Register notice: FDA announces a 5/31 public hearing to obtain scientific data and information about products containing cannabis or cannabis-...
Federal Register notice: FDA seeks comments on an information collection extension related to its Guidance: Emergency Use Authorization of Medical Pro...
Federal Register notice: FDA seeks comments on an information collection extension related to a guidance entitled Medical Device Accessories.
FDA releases the FDA-483 issued following a 2018 agency inspection at the Liveyon stem cell distribution facility.
FDA approves a TherOx PMA for its SuperSaturated Oxygen Therapy that is intended to provide interventional cardiologists with a treatment beyond percu...
FDA warns Inova Genomic Tests about illegally marketing genetic tests intended to predict how consumers will respond to specific drugs.