FDA clears a Moon Surgical 510(k) for its ScoPilot, an artificial intelligence-powered feature on the companys Maestro System intended to ensure a sta...
FDA grants Johnson & Johnson a fast track designation for its investigational therapy, nipocalimab and its use for treating adult patients with Sjgren...
Medtronic Neurovascular recalls its Compatible Pipeline Vantage Embolization (027) Devices and updating the use instructions for their 021 version due...
FDA rehires over 1,000 probationary employees that were fired last month after a Maryland federal judge ordered HHS and other federal agencies to rein...
Incyte says it will file an NDA for its JAK1 inhibitor povorcitinib and its use in adult patients with moderate to severe hidradenitis suppurativa, an...
Three former executives of Magellan Diagnostics plead guilty to federal charges after concealing a medical device malfunction involving lead test resu...
Orca Bio says its pivotal Phase 3 Precision-T study of Orca-T, an allogeneic T-cell immunotherapy, in certain leukemia patients met its primary endpoi...
FDA lifts a clinical hold against vTv Therapeutics cadisegliatin clinical program evaluating the first-in-class oral adjunctive therapy to insulin for...