A bipartisan group of five Senate Judiciary Committee members introduces legislation to establish an FDA/Patent and Trademark Office task force to imp...
HHS says FDA will lose about 3,500 (18%) of its 19,000 full-time employees under a just-announced reductions in force plan to consolidate activities a...
An exclusive Reuters report says FDA is likely to miss medical device user fee deadlines due to staff shortages from two rounds of cuts mandated by th...
FDA approves a Soleno Therapeutics NDA for Vykat XR (diazoxide choline) extended-release tablets for treating hyperphagia in individuals with Prader-W...
The Department of Justice reaches a settlement in which medical device company Prometheus and its owner agree to pay $550,000 to resolve False Claims ...
FDA accepts a Merck BLA for a subcutaneous formulation of Keytruda (pembrolizumab) for its use across all previously approved solid tumor indications....
FDA approves Fresenius Kabi BLAs for biosimilar denosumab products that reference Amgens Prolia and Xgeva.
FDA clears a Vasorum 510(k) for the Celt ACD Plus vascular closure device.
