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Plaisier Named New FDA Central Region Director

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FDA chooses associate commissioner for international programs Melinda Plaisier as its new Central Regional director, based in Chic...

Hispanics Dont Understand Atherosclerosis: Study

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An AstraZeneca-funded study shows that U.S. Hispanics have a lower awareness and understanding of atherosclerosis than of other he...

FDA Solicits Sunscreen Ingredient Info

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FDA requests safety and effectiveness information on ecamsule as a sunscreen ingredient.

FDA Hold on GVAX Prostate Cancer Trial

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FDA places a partial clinical hold on Cell Genesys terminated VITAL-2 GVAX prostate cancer immunotherapy program.

Allergan Planning Botox Migraine sBLA

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Allergan says it will file a Botox sBLA in 2009 for treating chronic migraine.

Black Box Warning on PML added to Rituxan

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Genentech and Biogen Idec revise the black box warning on Rituxan after a rheumatoid arthritis patient treated with the therapy de...

Priority Review for Kidney Cancer Drug

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FDA gives priority review to Novartis investigational advanced kidney cancer drug Afinitor.

FDA Approves Serdaxin Trial

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FDA approves a Phase 2 trial of Rexahns Serdaxin for treating major depressive disorder.

Proteon Drug Candidate on Fast Track

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FDA gives fast track designation to Proteon Therapeutics investigational drug PRT-201 for improving vascular access in dialysis pa...

Info on Radiopharmaceuticals Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on regulations for in vivo radiopharmaceuticals used for d...