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New Study Challenges Daily Treatment for Asthmatics

[ Price : $8.95]

A new study finds that mild-to-moderate asthma sufferers using a low-dose inhaled corticosteroid daily fared no better than those ...

Santarus Travelers Diarrhea Drug Meets Primary Endpoint

[ Price : $8.95]

Santarus Inc. reports positive Phase 3 data in evaluating rifamycin SV MMX, indicated to treat travelers diarrhea.

FDA Gets Level Funding in Agreement

[ Price : $8.95]

A congressional continuing resolution says FDA would receive its current level of funding for the next six months.

Actor Promoting Fluzone Intradermal Shots

[ Price : $8.95]

Sanofi Pasteur says it is working with actor Chris ODonnell to promote awareness of the need for flu vaccinations in adults and av...

Qualitest Recalls 1 Lot of Hydrocodone Tablets

[ Price : $8.95]

FDA says Qualitest is recalling one lot of hydrocodone bitartrate acetaminophen tablets due to the potential for acetaminophen ove...

FDA Will Review New Vyvanse Indication

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FDA says it will review a Shire sNDA for a new Vyvanse indication for maintenance therapy in children and adolescents ages 6-17 wi...

Woodcock: Biosimilars Need Paradigm Shift in Reviews

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CDER director Janet Woodcock says regulation of biosimilars will require a paradigm shift in treatment by reviewers of issues of e...

Sanofi Aventis Aubagio OKd for Multiple Sclerosis

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FDA approves Sanofi Aventis Aubagio for relapsing forms of multiple sclerosis in adults, but with liver-damage and birth defect wa...

National Surveillance System Runs Risk of Being a Burden: Stakeholders

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Stakeholders at an FDA public meeting on Strengthening the National Medical Device Postmarket Surveillance System caution that bui...

CDERs Evolving Benefit-risk Framework for Optimal Reviews

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A CDER official describes the development and purpose of an evolving benefit-risk framework to be used internally by review staff ...