FDA approves Progenics Pharmaceuticals Pylarify for PET imaging of prostate-specific membrane antigen positive lesions in some men with prostate cance...
FDA cautions New York Citys Metro Drug about adulterated and misbranded sterile drug products.
FDA says healthcare personnel and facilities can transition away from using non-NIOSH-approved disposable respirators due to an increased supply of ne...
FDA gives Acutus Medical the green light to initiate its atrial fibrillation clinical trial to assess the AcQBlate Force Sensing Ablation Catheter and...
FDA accepts for priority review a Janssen BLA for an investigational treatment for relapsed/refractory multiple myeloma.
FDA publishes two draft guidances on the continued surveillance of certain FDA-approved and cleared medical devices.
Federal Register notice: FDA announces the availability of FDA guidance documents related to the Covid-19 pandemic.
Federal Register notice: FDA updates its administrative records to reflect two Emergency Use Authorizations for biological products for use during the...