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Advisors Say Novartis CF Drug is Safe, Effective

[ Price : $8.95]

An FDA advisory committee says that Novartis demonstrated the safety and effectiveness of its tobramycin inhaled antibiotic powder...

Court Asked to Force FDA to Respond to Aricept Petition

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Public Citizen asks a federal court to order FDA to respond to its 2011 petition seeking withdrawal of Aricept 23.

FDA Defends Expedited Reviews After Critical Journal Article

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FDA defends its expedited review programs in the wake of a Journal of the American Medical Association article criticized the agen...

Priority Review for Janssens Bedaquiline

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FDA gives priority review to Janssens bedaquiline for treating some adults with tuberculosis.

Genomic Information Can Help Target Drug Development

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An Institute of Medicine workshop summary examines how genomic information can be used to improve the drug discovery and developme...

Sun Recalls One Lot of Nimodipine

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Sun recalls one lot of nimodipine capsules marketed by Caraco due to crystallization of fill material.

Sunovion Wants Generic Lunesta Requirements

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Sunovion petitions FDA to place conditions on possible approval of a Dr. Reddys ANDA for generic Lunesta.

FDA Clears LipoScience Clinical Analyzer

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FDA clears a LipoScience 510(k) for the Vantera Clinical Analyzer for measuring low density lipoprotein particles.

New Arthritis Biologics Don't Increase Cancer Risks: Researchers

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University of Texas MD Anderson Cancer Center researchers say that biologic therapies approved in the last decade for rheumatoid a...

FDA Approves Higher Dose Exelon Patch

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FDA approves a higher dose of Novartis Exelon Patch (rivastigmine transdermal system) for treating people with mild to moderate Al...