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Abbotts Navitor Approved for Aortic Stenosis

[ Price : $8.95]

FDA approves Abbotts latest-generation transcatheter aortic valve implantation system, Navitor, for treating people with severe ao...

Sterile Drug Issues at Optum Infusion

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FDA warns Chandler, AZ-based Optum Infusion Services about adulterated sterile drug products.

FDA Expands CN Bio Collaboration

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FDA expands its collaboration with CN Bio, adding research investigating the use of multi-organ microphysiological systems in esti...

Diagnostics, Dietary Supplement Reforms on FDA Legislative Agenda

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FDA deputy commissioner for policy, legislation and international affairs Andi Fristedt says her office continues to have its sigh...

Guide Seeks Dose Optimization in Cancer Drug Development

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FDA posts a draft guidance entitled Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of...

Texas Court Grants FDA Win in Vaccine EUAs

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A Texas federal court sides with FDA in a lawsuit opposing the Covid-19 vaccines emergency use authorizations for use in children....

Coviden Recalls Mahurkar Dialysis Catheter

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Medtronics Coviden unit recalls its Mahurkar 13.5Fr high-flow, dual lumen acute dialysis catheter based on a potential leaking con...

Novo Nordisks Rebelsus Now OK for 1st Line Use

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FDA approves a Novo Nordisk label update for Rybelsus (semaglutide) tablets 7 mg or 14 mg for a first-line treatment option for ad...

Man Pleads Guilty to Selling Used Medical Devices

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Kambiz Youabian (Tarzana, CA) pleads guilty to a two-count information charging him with mail fraud and introducing misbranded med...

AstraZeneca Discontinuing Lumoxiti for Hairy Cell Leukemia

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AstraZeneca says it is permanently discontinuing sales of Lumoxiti (moxetumomab pasudotox-tdfk) for injection, indicated for treat...