Three congressmen introduce the Alternatives to Animals for Regulatory Fairness Act to reduce animal testing by drug companies.
Moderna says its investigational Covid-19 vaccine is showing a 94.5% efficacy rate based on a NIH-appointed data safety monitoring board interim analy...
FDA commissioner Stephen Hahn says the agency has added about 1,000 new staff in fiscal year 2020 due to a streamlined hiring spree authorized by the ...
FDA issues Adamis Pharmaceuticals a second complete response letter on its NDA for Zimhi, a high-dose naloxone injection product for treating opioid o...
FDA makes available a draft guidance entitled Electromagnetic Compatibility (EMC) of Medical Devices.
Federal Register notice: FDA makes available a final guidance #197 entitled Documenting Electronic Data Files and Statistical Analysis Programs.
FDA sends Sanofi a complete response letter on its BLA for sutimlimab, an investigational monoclonal antibody for treating hemolysis in adults with co...