Federal Register notice: FDA seeks comments on an information collection revision entitled Generic Drug User Fee Program to allow controlled correspon...
As he prepares to resign his post, FDA commissioner Robert Califf posts what is likely his final essay and personal reflection on the safety and effec...
FDA accepts for priority review an AstraZeneca and Daiichi Sankyo BLA for datopotamab deruxtecan for treating certain adult patients with locally adva...
Philips recalls its Monitoring Service Application concerning the Mobile Cardiac Telemetry Monitoring (BTPS-1000) system after identifying that some e...
FDA releases guidance entitled Premarket Approval Application (PMA) and Humanitarian Device Exemption (HDE) Modular Review.
FDA grants Rigel Pharmaceuticals an orphan drug designation for R289 and its use in treating myelodysplastic syndromes.
CDER director Patrizia Cavazzoni unexpectedly announces her early retirement effective two days before the new Trump administration comes to power.
Over 18,000 appalled physicians sign an open letter urging the U.S. Senate to reject the nomination of Robert F. Kennedy Jr. to serve as HHS secretary...
