An FDA online paper explains how the agency is leveraging its international collaboration activities to help respond to the Covid-19 pandemic.
FDA approves a Medtronic PMA for the Percept PC Deep Brain Stimulation system for treating patients with neurologic disorders associated with Parkinso...
Public Citizen says the federal government should use its interest in patents shared with Moderna for a Covid-19 vaccine candidate to ensure that the ...
FDA approves Mercks Keytruda (pembrolizumab) as monotherapy for treating patients with recurrent or metastatic cutaneous squamous cell carcinoma that ...
Federal Register notice: FDA makes available a final guidance entitled Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment.
Federal Register notice: FDA makes available a final guidance entitled Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneum...
BIO says an FDA draft guidance on interpreting gene therapy product sameness is helpful and asks that the agency state that the draft does not cover g...
Three stakeholders raise concerns about an FDA draft guidance on technical considerations to show the reliability of emergency-use injectors.