FDA clears an Additive Implants 510(k) for the SureMAX-X Cervical Spacer, a 3D-printed titanium spinal surgery device.
CBER releases a list of 21 guidances it may develop and issue in 2020.
The Justice Department says a former senior generic drug company executive is the third person to plead guilty to participating in a conspiracy to fix...
Federal Register notice: FDA opens a docket to obtain information about vaping products and associated lung injuries.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Endorecherches Intrarosa (prasterone).
Federal Register notice: FDA announces a 3/10 public meeting entitled Patient-Focused Drug Development for Stimulant Use Disorder.
Philips Respironics recalls its Trilogy EVO Ventilator and Trilogy EVO Universal Ventilator due to a software defect.
FDA says a joint enforcement operation conducted with India stopped about 500 shipments of illicit and potentially dangerous unapproved prescription d...