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...
Federal Register notice: FDA makes available a draft guidance entitled Postoperative Nausea and Vomiting: Developing Drugs for Prevention.
Federal Register notice: FDA makes available a final guidance entitled Core Patient-Reported Outcomes in Cancer Clinical Trials.
Federal Register notice: FDA makes available a final guidance entitled Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neon...
