FDA grants an emergency use authorization to Cellex for a coronavirus serology test.
FDA approves a Rudy Giuliani-touted Celularity IND for its investigational stem cell therapy in Covid-19 patients.
FDA releases the FDA-483 with three observations issued following an inspection at Malaysias Biocon Sdn Bhd.
FDA announces a 5/5 public meeting entitled Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027 that will be available by Webcast.
Federal Register notice: FDA proposes to reclassify certain hepatitis C virus antibody assay devices from Class 3 to Class 2 (general controls and spe...
The ICH says the Medical Dictionary for Regulatory Activities is being updated to standardize coding of the coronavirus.
FDA releases the FDA-483 with 10 inspection observations from an inspection of Immunomedics, Inc.
FDA gives Vanda Pharmaceuticals approval to begin a clinical study of tradipitant in hospitalized patients with Covid-19-related pneumonia.