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Panel Backs Novo Nordisk Diabetes Drug

[ Price : $8.95]

FDAs Endocrinologic and Metabolic Drugs Advisory Committee votes 16-0 to recommend approval of Novo Nordisks once-weekly semagluti...

Court Dismisses FTC Prevagen Case

[ Price : $8.95]

Attorney Ritte van Laack says a New York federal court dismissed an FTC suit alleging that Quincy Bioscience made unsubstantiated ...

FDA Approves Nexus Generic Procainamide

[ Price : $8.95]

FDA approves Nexus Pharmaceuticals procainamide HCl injection as a multi dose vial containing 1,000 mg per 2 mL or as a multi dose...

CDRH Real-World Evidence Questions Answered

[ Price : $8.95]

A CDRH webinar on real-world evidence responds to questions and comments posed in response to the Centers recent guidance.

Octapharma Withdraws 2 Octagam Lots

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FDA says Austrias Octapharma has withdrawn two lots of its octagam 10% from the market after consulting with FDA.

Court Says Eye Drop Case is Preempted

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Attorney Michelle Yeary says a Massachusetts federal court ruled that a suit alleging that drug companies packaged eye drops in di...

Merck BioReliance Facility Passes FDA Inspection

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Merck says its California viral and gene therapy manufacturing facility passed an FDA inspection.

Kite Pharma CAR-T Cell Therapy Approved

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FDA approves a Kite Pharma NDA for Yescarta (axicabtagene ciloleucel), a cell-based gene therapy for treating adult patients with ...

FDA Grants Pluristem Therapeutics Orphan Drug Status

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FDA grants Pluristem Therapeutics an orphan drug designation for its PLX-R18 cell therapy for preventing and treating acute radiat...

CDRH Seeks Experiential Learning Partners

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Federal Register notice: CDRH announces its 2018 Experiential Learning Program.