The House Energy and Commerce Committee seeks additional inspection records from FDA after its analysis of the foreign drug inspection program found t...
FDA denies a 4/2023 petition that called on the agency to withdraw approval for Harmony Biosciences Wakix (pitolisant) and take other actions against ...
FDA approves Halozyme Therapeutics Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for treating chronic inflammatory demyelinating polyneur...
Federal Register notice: FDA announces a 7/22 public workshop entitled Best Practices for Meeting Management.
Federal Register notice: FDA announces a publication containing modifications it is making to the list of standards FDA recognizes for use in premarke...
Federal Register notice: FDA determines that Janssen Pharmaceuticals Invega (paliperidone) extended-release tablet was not withdrawn from sale due to ...
FDA converts Janssens Sirturo (bedaquiline) from accelerated to traditional approval following a determination that a confirmatory trial verified clin...
Federal Register notice: FDA makes available a draft guidance entitled Considerations in Demonstrating Interchangeability With a Reference Product: Up...
