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FDA Accepts Vertex sNDA for Kalydeco

[ Price : $8.95]

FDA accepts a Vertex Pharmaceuticals supplemental NDA for the use of Kalydeco (ivacaftor) in patients eople with cystic fibrosis a...

FDA Denies Part of Phthalates Petition

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FDAs Center for Food Safety and Applied Nutrition denies a portion of a citizen petition seeking a regulation banning use of phtha...

FDA Helps Find Enzyme Controller

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Scientists from FDAs National Center for Toxicological Research and two other entities say they have found a microRNA that control...

FDA Cautions Against Incorrect Allergenic Nomenclature

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CBER cautions six companies about failing to use correct and consistent nomenclature on their licensed non-standardized allergenic...

Califf Took Name Off Articles Critical of FDA

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The Boston Globe reports that FDA commissioner-nominee Robert Califf asked that his name be removed from a series of journal artic...

Injunction Against SD Laser Manufacturer

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A South Dakota federal judge approves a permanent injunction sought by FDA to prevent 2035 Inc. and its president, Robert Lytle, f...

FDA Clinical Hold on Advaxis Trials After Patient Death

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FDA places on clinical hold four Advaxis clinical trials involving axalimogene filolisbac in response to a recent report from the ...

FDA Approves Insightecs Exblate for Uterine Fibroids

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FDA approves Insightecs Exablate system to treat symptomatic uterine fibroids with MRI guidance.

FDA Clears Luminex ARIES HSV System and Assay

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FDA clears a Luminex Corp. 510(k) for the ARIES System and ARIES HSV 1&2 Assay, which is intended for use in detecting herpes simp...

Petition Seeks Contraindications for Anticoagulants

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Self-described whistleblower David Cundiff asks FDA to revoke approval for anticoagulant drugs as stroke prophylaxis for non-valvu...