AstraZeneca announces positive progression-free survival results from the Phase 3 POSEIDON trial in previously-untreated Stage IV non-small cell lung ...
Medtronic gets an FDA Breakthrough Device designation for its fully implantable left ventricular assist device for patients with advanced heart failur...
FDA issues a draft guidance and a final technical conformance guide on electronic submission of IND safety reports to the FDA Adverse Event Reporting ...
An FDA-led drug shortage task force releases a report highlighting key reasons for drug shortages and potential enduring solutions.
Federal Register notice: FDA makes available a draft guidance for industry entitled Type V DMFs for CDER-Led Combination Products Using Device Constit...
Federal Register notice: FDA classifies self-fitting air-conduction hearing aids into Class 2 (special controls).
Federal Register notice: FDA posts a list of FDA information collections recently approved by OMB.
FDA updates a 2018 safety alert about Endologixs AFX endovascular graft systems used in treating abdominal aortic aneurysms and the risks associated w...