FDA grants Nyxoah a breakthrough device designation for its Genio bilateral hypoglossal nerve stimulation system and its use in treating patients with...
FDA clears Anika Therapeutics Tactoset for an expanded indication.
FDA removes a clinical hold against KalVista Pharmaceuticals and its Phase 2 clinical trial of KVD824 for oral prophylactic treatment of hereditary an...
Federal Register notice: FDA withdraws three NDAs because the application holders have repeatedly failed to file required annual reports.
A Lancet article authored by two retiring senior FDA vaccine officials and other researchers argues against requiring Covid-19 booster shots until dat...
Federal Register notice: FDA announces an 11/4 Blood Products Advisory Committee meeting that will hear CBER research updates.
Federal Register notice: FDA consolidates regulatory oversight responsibilities in CBER for certain devices, and accordingly fat transfer devices with...
FDA posts a draft International Conference for Harmonization guideline entitled Nonclinical Biodistribution Considerations For Gene Therapy Products I...