Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for Pfizers Vyndaqel (tafamidis meglumine).
FDA accepts for review an Elevar Therapeutics NDA resubmission for its investigational drug rivoceranib, in combination with camrelizumab, as a first-...
FDA clears an iRhythm Technologies 510(k) related to prior design changes made to the Zio AT cardiac telemetry device.
A coalition of 18 attorneys general file a Fourth Circuit appellate brief in support of a lower court decision finding that North Carolina cannot impo...
House Energy and Commerce Committee republicans ask HHS inspector general Christi Grimm to assess the adequacy of FDAs oversight and support of its Of...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Pfizers Vyndamax (tafamidis).
FDA approves an Astellas Pharma BLA for Vyloy (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the f...
GE Healthcare recalls its Giraffe OmniBed neo-natal incubator after receiving reports about the screw that secures the door becoming loose.
