FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Medical Devices

Moon Surgicals AI-enabled ScoPilot Cleared

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...

latest-news-card-1
Human Drugs

J&J Gets Fast Track for Sjgrens Drug

FDA grants Johnson & Johnson a fast track designation for its investigational therapy, nipocalimab and its use for treating adult patients with Sjgren...

latest-news-card-1
Medical Devices

Medtronic Recalls Vantage Embolization Devices

Medtronic Neurovascular recalls its Compatible Pipeline Vantage Embolization (027) Devices and updating the use instructions for their 021 version due...

latest-news-card-1
FDA General

FDA Rehires Fired Employees Due to Court Order

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...

latest-news-card-1
Human Drugs

Incyte Plans NDA for JAK1 Inhibitor for Skin Condition

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...

latest-news-card-1
Medical Devices

Ex-Magellan Execs Plead Guilty in Device Scandal

Three former executives of Magellan Diagnostics plead guilty to federal charges after concealing a medical device malfunction involving lead test resu...

Biologics

Orca Bio T-Cell Leukemia Trial Meets Endpoint

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...

latest-news-card-1
Human Drugs

Hold Removed on vTv Therapeutics Diabetes Trial

FDA lifts a clinical hold against vTv Therapeutics cadisegliatin clinical program evaluating the first-in-class oral adjunctive therapy to insulin for...

latest-news-card-1
Human Drugs

Positive Hypoparathyroidism Trial Data: AstraZeneca

AstraZeneca reports positive data from the CALYPSO Phase 3 hypoparathyroidism trial, showing eneboparatide met its primary endpoint.

FDA General

Thousands of FDA Employees Return to Office

Thousands of FDA employees return to their offices 3/17 and deal with logistical issues, such as traffic, parking and finding work spaces.