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Grassley Questions Heart Valve Device Approval

[ Price : $8.95]

Sen. Charles Grassley raises questions about an Edward Lifesciences heart valve repair ring that he says is being implanted in pat...

Advisors Back Coartem Approval

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Members of FDAs Anti-infective Advisory Committee recommend approval of Novartis Coartem for treating malaria.

Cardiologist: Apply Marketing Techniques to Safety Monitoring

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University of Colorado cardiologist David Kao says drug company marketing techniques should be used to promote drug safety in post...

FDA Orphan Status for Allos Therapy

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FDA grants an orphan drug designation to Allos Therapeutics for its pralatrexate, an antifolate indicated for treating patients wi...

Co. Execs Say DTC Ads are Industrys Worst Decision

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Roche and Shire senior executives blast direct-to-consumer promotion during a London financial conference.

Journal Editorials Dont Support Generic Drug Use

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Researchers report in JAMA that many journal editorials caution that generic cardiovascular drugs may not be equivalent to branded...

Group Takes on Internet Video Device Ads

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The Prescription Project says FDA should take enforcement action against online video ads for drugs and devices that dont carry re...

Schering-Plough Plans New Trial for Bridion

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After receiving an NDA not approvable decision, Schering-Plough says it plans to conduct an allergy sensitivity trial in healthy v...

FDA Accepts NDA for Antibiotic

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FDA accepts an Advanced Life Sciences Holdings NDA for cethromycin, a once-a-day oral antibiotic intended for use in treating mild...

Panel Briefing Document Backs Allergan Eyelash Therapy

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An FDA advisory committee briefing document supports approval of Allergans Lumigan for use in improving eyelashes.