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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 cons...[ Price : $8.95]
An exclusive Reuters report says FDA is likely to miss medical device user fee deadlines due to staff shortages from two rounds of...[ Price : $8.95]
FDA approves a Soleno Therapeutics NDA for Vykat XR (diazoxide choline) extended-release tablets for treating hyperphagia in indiv...[ Price : $8.95]
The Department of Justice reaches a settlement in which medical device company Prometheus and its owner agree to pay $550,000 to r...[ Price : $8.95]
FDA accepts a Merck BLA for a subcutaneous formulation of Keytruda (pembrolizumab) for its use across all previously approved soli...[ Price : $8.95]
FDA approves Fresenius Kabi BLAs for biosimilar denosumab products that reference Amgens Prolia and Xgeva.[ Price : $8.95]
FDA clears a Vasorum 510(k) for the Celt ACD Plus vascular closure device.[ Price : $8.95]
A Senate floor vote moves Marty Makary one step closer to becoming the next FDA commissioner.