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.
A Senate floor vote moves Marty Makary one step closer to becoming the next FDA commissioner.
FDA warns Chinas Yangzhou Sion Commodity Co. about CGMP violations in its manufacturing of finished drugs.