FDAs Oncology Center of Excellence unveils a new drug expanded access pilot program to assist oncology health care professionals in requesting access ...
Federal Register notice: FDA withdraws the approval of five ANDAs for products containing pemoline.
Federal Register notice: FDA permits the redemption of a priority review voucher associated with the recent approval of a Novartis NDA for Mayzent (si...
FDA issues a safety alert on the dietary supplement ingredient vinpocetine (aka periwinkle extract) due to its potential to cause a miscarriage or har...
FDA chief of staff Lauren Silvis announces her departure from the agency later this month.
Center for Science in the Public Interest and former associate commissioner Peter Lurie says that FDA needs to be more transparent and announce when c...
The Justice Department charges generic drug maker Heritage Pharmaceuticals for conspiring with its competitors to fix prices, rig bids, and allocate c...