FDA clears an Abbott 510(k) for its latest optical coherence tomography (OCT) imaging platform powered by the companys new Ultreon Software.
FDA lifts a partial clinical hold against a Novartis investigational gene therapy OAV-101 intrathecal clinical trial for spinal muscular atrophy.
A Senate appropriations subcommittee votes to advance FDAs fiscal year 2022 budget with a $200 million (6%) spending boost.
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.