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Advaxis Pre-IND Meeting for HER2 Therapy

[ Price : $8.95]

Advaxis completes a pre-IND meeting with FDA that discussed the development plan for ADXS-HER2 for treating HER2-expressing cancer...

FDA Approves Promus Element Stent System

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FDA approves Boston Scientifics Promus Element Plus next-generation drug eluting stent system.

Shire Seeks to Move Vpriv Manufacturing

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Shire files an NDA manufacturing supplement seeking approval to begin production of Vpriv (velaglucerase alfa) at its manufacturin...

FDA Could Do More to Combat Economic Adulteration: GAO

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The Government Accountability Office calls for greater FDA efforts to combat economic adulteration of drugs and food.

Supercommittees Failure Could be Dire for FDA Budgets

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The Congressional supercommittee's failure this week to come to terms on a deficit reduction plan leaves FDA and other agencies fa...

Amalgam Risk Study Submitted to FDA is on Journals Most Read List

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A key study on dental amalgam mercury vapor exposure that's been under review at CDRH for a year makes a scientific journals most-...

FDA Will Review Arcalyst sBLA

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FDA says it will review Regenerons sBLA for Arcalyst seeking an indication for preventing gout flares in certain patients.

FDA Denies Public Citizen Avandia Petition

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Public Citizen Health Research Group director Sidney Wolfe blasts FDA for rejecting his groups petition asking that GlaxoSmithKlin...

Medtronic New Glucose Monitor Approved

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FDA approves Medtronics iPro2, a next-generation continuous glucose monitoring system.

CGMP Violations Found at Jenahexal Plant

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FDA warns Jenahexal Pharm about CGMP and other violations in its homeopathic drug manufacturing facility in Germany.