FDA clears a Royal Philips 510(k) for its Philips Zenition 30 mobile C-arm imaging device.
FDA announces that its Medical Devices Advisory Committees Molecular and Clinical Genetics Panel is scheduled to review a Guardant Health PMA for its ...
FDA issues Abeona Therapeutics a complete response letter on a BLA for prademagene zamikeracel (pz-cel), requesting additional information to satisfy ...
Endos Par Pharmaceutical recalls seven lots of treprostinil injection 20g/20mL due to the potential for the presence of silicone particulates in the p...
Federal Register notice: FDA seeks comments on an information collection extension entitled Data To Support Social and Behavioral Research as Used by ...
Pharmaceutical Research and Manufacturers of America urges FDA to hold more meetings on innovative clinical trial approaches to allow more discussion ...
Draeger Medical recalls its Draeger Perseus A500 Anesthesia Workstation due to the potential for an unexpected shutdown while operating on battery pow...
FDA orders a Boxed Warning to highlight the serious risk of T cell malignancies following administration of BCMA-directed or CD-19-directed autologous...
