Draeger Medical recalls (Class 1) its VentStar and ID Breathing Circuits and Anesthesia Sets manufactured 1/2016 to 11/2018 due to incorrect assembly ...
FDA downplays earlier safety concerns about some generic versions of angiotensin II receptor blocker medicines that contain nitrosamine impurities, wh...
FDA clears a Zimmer Biomet Holdings 510(k) for the Rosa Knee System for robotically-assisted total knee replacement surgeries.
FDA says that after the partial government shutdown ends it will extend or reopen the comment period on an 11/20/2018 Federal Register notice entitled...
FDA lifts a partial clinical hold against MacroGenics and its Phase 1 monotherapy and combination studies of cancer drug MGD009, a B7-H3 CD3 bispecifi...
Furloughed FDA employees are expected to return to work early next week under a 1/25 tentative agreement reached between President Trump and Congress ...
FDA approves a CorMatrix Cardiovascular early feasibility study IDE to evaluate the safety and feasibility of the Cor Tricuspid ECM cardiac valve for ...
FDA releases two draft guidances to help companies develop REMS assessment plans concurrently with the plans themselves.