On FDAs orders, U.S. marshals seize FDA-regulated products that the agency says were being held under insanitary conditions that exposed them to wides...
FDA approves a Theravance Biopharma and Mylan NDA for Yupelri (revefenacin) inhalation solution for the maintenance treatment of patients with chronic...
Attorney Jeffrey Shapiro says FDA should seek congressional authority to continue to regulate some medical devices as drugs.
FDA has granted Korea-based Vivozon a fast track designation for VVZ-149, a non-opioid pain killer.
FDA says it is updating its Expanded Access Web pages and taking other steps to improve the program for patients and healthcare providers.
Former Pfizer executive John LaMattina says FDA should consider ways to streamline cardiovascular outcome trials for diabetes drugs to lower the cost ...
FDA says it has cleared a new Monteris Medical probe to replace one that was recalled due to unintended overheating in the magnetic resonance environm...
Federal Register notice: FDA determines that Eli Lillys Axiron (testosterone) transdermal metered solution, 30 mg/1.5 ml actuation was not withdrawn f...