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Aflibercept Pancreatic Cancer Trial Halted

[ Price : $8.95]

Sanofi-Aventis and Regeneron say they are terminating a Phase 3 study of aflibercept plus gemcitabine in treating metastatic pancr...

Discovery, FDA Meet 9/29 on Surfaxin NDA

[ Price : $8.95]

Discovery Laboratories will present a limited clinical trial proposal to FDA 9/29 in an effort to move its Surfaxin NDA forward.

Cutler Touchdowns Add Scholarship Funds

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Eli Lilly says it will pay for Chicago Bears quarterback Jay Cutlers touchdown passes and pass completions to help fund scholarshi...

FDA Details Warning Letter Close Out Process

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FDA releases new details about when Warning Letter close-out letters can be issued as part of commissioner Margaret Hamburgs new e...

FDA Reviews PMA for Dermal Filler

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FDA accepts for review a Merz Pharmaceuticals PMA for Belotero Balance, a hyaluronic acid-based monophasic gel dermal filler.

Covidien Recalls CO2 Detector

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FDA says that Covidien has recalled lots of its Pedi-Cap CO2 detector due to a problem that could lead to serious adverse health c...

FDA Says ConMed Recall is Class 1

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FDA classifies ConMeds recall of handpieces and cables as Class 1.

Ophena NDA Due Next Year

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QuatRx says it will submit an NDA to FDA early next year for its Ophena treatment for vaginal symptoms associated with menopause.

FDA Wants More Trabectedin Data, Studies

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FDAs complete response letter on Centocor Ortho Biotechs trabectedin asks for additional survival data and clinical pharmacology s...

Advisors Support Male Gardasil Use

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FDAs Vaccines and Related Biological Products Advisory Committee recommends approval of Mercks Gardasil for an indication to preve...