FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Opdivo (nivolumab) and its use in combination with AVD chemotherapy for ad...
An independent assessment of the FDA Total Product Lifecycle Advisory Program pilot finds it met its objectives exceptionally well and has several opp...
FDA approves the first at-home, prescription-only brain-stimulation device to treat major depressive disorder.
Rep. Jan Schakowsky and Sen. Dick Durbin reintroduce their Medical Device Recall Improvement Act to improve medical device recall communications betwe...
Serina Therapeutics files a complete response to an FDA clinical hold on SER-252, the companys lead investigational therapy for advanced Parkinsons di...
FDA weighs changes to a long-standing labeling rule for dietary supplements and will temporarily exercise enforcement discretion on certain disclaimer...
The U.S. government urges the Supreme Court to take up a patent-infringement dispute to decide whether generic drugmakers may face liability for induc...
Researchers say that the enhanced FDA regulatory authority from the 2017 FDA Amendments Act did not significantly change the time to first agency post...
