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Hep D Virus Drug Development Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Chronic Hepatitis D Virus Infection: Developing Drugs for T...

Draft Guide on Generic Drug User Fees

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Federal Register notice: FDA makes available a draft guidance entitled Assessing User Fees under the Generic Drug User Fee Amendme...

Trump Taps MD Andersons Hahn as FDA Head

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President Donald Trump chooses to nominate MD Anderson chief medical officer Stephen Hahn to be FDA commissioner.

Panel to Review Correvio Atrial Fibrillation Drug

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Federal Register notice: FDA has announced a 12/10 Cardiovascular and Renal Drugs Advisory Committee meeting to discuss a Correvio...

Novartis Trial Misses Superiority in Cosentyx Trial

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Novartis says its EXCEED head-to-head trial comparing Cosentyx (secukinumab) to AbbVies Humira (adalimumab) in patients with activ...

NDMA Testing on Ranitidine Better Than First Thought: FDA

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An FDA update on an ongoing investigation about a contaminant known as N-Nitrosodimethylamine found in ranitidine (Zantac) says th...

Xact Robotics Percutaneous Interventional Device Cleared

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FDA clears an Xact Robotics 510(k) for its robotic system and its use during computed tomography guided percutaneous interventiona...

Thoratec Recalls CentriMag Systems

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Thoratec Switzerland recalls its CentriMag Acute Circulatory Support System Motor, which is a component of the CentriMag Extracorp...

Mexitil Not Withdrawn Over Safety/Efficacy: FDA

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Federal Register notice: FDA determines that Boehringer Ingelheims Mexitil (mexiletine hydrochloride) was not withdrawn from sale ...

Stryker Sahara Lateral 3D Spine Implant Cleared

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FDA clears a Stryker 510(k) for its Sahara Lateral 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology.