FDA issues Eton Pharmaceuticals a complete response letter on its NDA for dehydrated alcohol injection for treating methanol poisoning.
Federal Register notice: FDA revokes Battelle Memorial Institutes emergency use authorization for the Battelle Critical Care Decontamination System.
Federal Register notice: FDA revokes a BioFire Diagnostics emergency use authorization for its BioFire Respiratory Panel 2.1 after the company was gra...
FDA approves Amgens Lumakras (sotorasib) for treating adult patients with non-small cell lung cancer whose tumors have the KRAS G12C genetic mutation....
The DC Circuit Court of Appeals affirms a lower court decision recognizing FDAs authority to place homeopathic drugs on its import alert listing after...
FDAs fiscal year 2022 budget request seeks an 8% ($477 million) boost for agency activities.
Federal Register notice: FDA withdraws a notice by the previous administration that would have ended the agencys unapproved drugs initiative.
Federal Register notice: FDA makes available a draft guidance entitled Procedures for Handling Post-Approval Studies Imposed by Premarket Approval App...