Federal Register notice: FDA makes available a final guidance entitled Priority Zoonotic Animal Drug Designation and Review Process.
FDA sends Daiichi Sankyo and Merck a complete response letter on their BLA for patritumab deruxtecan (HER3-DXd) for treating certain adult patients wi...
Rep. Jan Schakowsky and seven others introduce legislation to authorize the importation of prescription drugs from Canada, the UK, the European Union,...
CDER and CBER announce seven participants in the START pilot program to speed development of treatments for rare diseases.
FDA releases the form FDA-483 with five observations from an inspection at the Torrent Pharmaceuticals facility in Indrad, Gujarat, India.
FDA grants a de novo marketing authorization to Cepheid for its Xpert HCV test and GeneXpert Xpress System for detecting hepatitis C virus.
CDRH says it is partnering with the Bill and Melinda Gates Foundation and the National Institute for Standards and Technology on a project to develop ...
Federal Register notice: FDA submits to OMB a proposed information collection entitled Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP...
