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FDA Outlines Concerns with Unapproved GLP-1 Drugs

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FDA posts its concerns with unapproved GLP-1 drugs used for weight loss.

Moon Surgicals AI-enabled ScoPilot Cleared

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FDA clears a Moon Surgical 510(k) for its ScoPilot, an artificial intelligence-powered feature on the companys Maestro System inte...

J&J Gets Fast Track for Sjgrens Drug

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

Medtronic Recalls Vantage Embolization Devices

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Medtronic Neurovascular recalls its Compatible Pipeline Vantage Embolization (027) Devices and updating the use instructions for t...

FDA Rehires Fired Employees Due to Court Order

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FDA rehires over 1,000 probationary employees that were fired last month after a Maryland federal judge ordered HHS and other fede...

Incyte Plans NDA for JAK1 Inhibitor for Skin Condition

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Incyte says it will file an NDA for its JAK1 inhibitor povorcitinib and its use in adult patients with moderate to severe hidraden...

Ex-Magellan Execs Plead Guilty in Device Scandal

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Three former executives of Magellan Diagnostics plead guilty to federal charges after concealing a medical device malfunction invo...

Orca Bio T-Cell Leukemia Trial Meets Endpoint

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Orca Bio says its pivotal Phase 3 Precision-T study of Orca-T, an allogeneic T-cell immunotherapy, in certain leukemia patients me...

Hold Removed on vTv Therapeutics Diabetes Trial

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FDA lifts a clinical hold against vTv Therapeutics cadisegliatin clinical program evaluating the first-in-class oral adjunctive th...

Positive Hypoparathyroidism Trial Data: AstraZeneca

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