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Hugel Refiles BLA Addressing FDA Concerns

[ Price : $8.95]

Korea-based Hugel resubmits its BLA for its botulinum toxin Letybo (letibotulinumtoxinA), indicated for treating glabellar (frown)...

Sage Reorganizing to Support Zurzuave Launch

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Sage Therapeutics says it is downsizing and reorganizing to prepare for the launch of its postpartum depression drug Zurzuave late...

BD Suggestions for Microbiology Panel

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Becton Dickinson asks the FDA Microbiology Devices Panel to consider four points at its 9/8 discussion of diagnostic devices in fu...

Datascope Recalls Cardiosave Pumps Over Alarm

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Datascope begins an FDA-rated Class 1 recall of its Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) due t...

Enhanced Drug Distribution Security Guide

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Federal Register notice: FDA makes available a final guidance entitled Enhanced Drug Distribution Security at the Package Level Un...

Guide on Real-World Data/Evidence

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Federal Register notice: FDA makes available a final guidance entitled Considerations for the Use of Real-World Data and Real-Worl...

AdvaMed on At-Home Medical Technology Use

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AdvaMed lists steps the federal government could take to improve patient access to at-home medical technologies.

Alcrestas ReliZorb Cleared for Younger Children

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FDA clears an Alcresta Therapeutics 510(k) for an expanded use for ReliZorb in children ages two to five years.

Blood Monitor Cleared for Cardiopulmonary Bypass

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FDA clears a LivaNova 510(k) for its Essenz In-Line Blood Monitor that provides continuous measurement of essential blood paramete...

Fight Bone Graft Infections: Michigan Lawmakers

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Four members of Congress from Michigan call on FDA to do more to prevent infections from contaminated bone grafts.