Abbott recalls its CentriMag Acute Circulatory Support System due to a calibration system error.
FDA says a requested clinical trial did not alleviate an overall survival trend that it was concerned with in an earlier Aveo Oncology study of tivoza...
Aquestive Therapeutics asks FDA not to approve Neurelis Valtoco until the company performs additional studies like those Aquestive performed for its L...
Tonix Pharmaceuticals says that after receiving input from FDA, it is changing elements of its Phase 3 study of its Tonmya PTSD treatment.
FDA principal deputy commissioner Amy Abernathy says the agency is overhauling its technology infrastructure to be prepared to cope with a coming wave...
FDA updates its online records on post-market activities and studies of Bayers withdrawn Essure birth control device.
FDA Review posts the Federal Register notice for the week ending 8/1/2019.