FDA clears a RealView Imaging 510(k) for its Holoscope-i holographic system for creating spatially accurate, three-dimensional interactive medical hol...
Federal Register notice: FDA denies a request for a hearing submitted by Vithal K. Patel and issues an order debarring him for one year from providing...
Federal Register notice: FDA denies Belen G. Ngos request for a hearing and is issuing an order debarring her for five years from providing services r...
FDA approves an AstraZeneca BLA for Saphnelo (anifrolumab-fnia) for treating adult patients with moderate to severe systemic lupus erythematosus.
Federal Register final rule: FDA issues a final rule to amend its medical product intended use regulations.
FDA defends the accelerated approval process in the wake of Biogens controversial Alzheimers approval and a new BMJ report that since the programs inc...
FDA grants Biofourmis a breakthrough device designation for BiovitalsHF, a software medical application that is intended to augment guideline-directed...