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Panel to Discuss Daiichi Sankyo NDA for Preventing Stroke/Embolism

[ Price : $8.95]

Federal Register Notice: FDAs Cardiovascular and Renal Drugs Advisory Committee will meet 10/30 to discuss a Daiichi Sankyo NDA fo...

Public Workshop Scheduled on E-Cigarettes

[ Price : $8.95]

Federal Register Notice: FDAs Center for Tobacco Products will hold a public workshop 12/10-11 to discuss electronic cigarettes.

Soligenix, FDA Reach Agreement on Lymphoma Trial

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Soligenix reaches an agreement with FDA on the design of a Phase 3 clinical trial of its synthetic hypericin product for treating ...

FDA Employees Rank FDA Lower on Best of Survey

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FDA slips in the annual agency rankings of Best Places to Work in the Federal Government.

Ariad Gets FDA OK to Return Iclusig to Market

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FDA approves Ariad Pharmaceuticals plan to return its leukemia drug Iclusig (ponatinib) to the market.

Covis Pharma Cited for Promo Violations

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CDERs Office of Prescription Drug Promotion sends an untitled letter to Covis Pharmaceuticals over a physician letter promoting La...

FDA Hits Amarin Pharma with Promotional Violation Letter

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FDA objects to an Amarin Pharmaceuticals promotional Rapid Overview Webcast Series - Print Invitation for Vascepa (icosapent ethy...

Novo Nordisk Files NDA for Weight Management

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Novo Nordisk files an NDA with FDA for a 3 mg dose of liraglutide for chronic weight management.

Illinois Court Has Different Take on Preemption: Lawyers

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A medical device product liability lawsuit overcomes a federal preemption defense by relying on a controversial Seventh Circuit Co...

Caronia Decision Dissected in Harvard Law Review

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This months Harvard Law Review takes a look at the year-old Caronia court decision and finds that while it is defensible as a matt...