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Biogen Idec MS Drug Review Time Extended

[ Price : $8.95]

FDA extends for three months its PDUFA review deadline for Biogen Idecs dimethyl fumarate for treating multiple sclerosis.

FDA Should Work with Industry on Study Data Standards: Sanofi

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Sanofi asks FDA to continue working with industry on many aspects of clinical study data standards.

Quality Problems at Drug Manufacturing Plants Aired

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A New York Times report details quality problems found by FDA at many drug manufacturing facilities.

FDA Beefing Up Medical Device Security

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CDRH tells Govinfosecurity.com it is taking steps to improve medical device safety and security.

Abbott Loses Potential Blockbuster Bardoxolone

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In a significant financial blow, Abbott says it and Reata Pharmaceuticals are ending a late-stage trial of bardoxolone to treat ki...

FDA OKs Lupin Generic Contraceptive

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FDA grants final approval to Lupin Pharmaceuticals to market its Kurvelo tablets, a generic version of Tevas oral contraceptive No...

Merck Serono, Auxogyn to Collaborate on Embryo Test

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Merck Serono and Auxogyn, Inc. have entered into an agreement in which Merck Serono will provide support for Auxogyns Early Embryo...

Fungus Confirmed in Compounded Steroid Vials

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FDA says laboratory testing found a fungus in unopened vials of steroids compounded by the New England Compounding Center that hav...

Reject Mipomersen NDA: Public Citizen

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Public Citizen says FDA should deny approval for a Genzyme NDA for mipomersen, a cholesterol-lowering drug.

PDUFA Transparency Meetings Key to First Cycle Approvals: FDA

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CDER Office of New Drugs associate director for regulatory affairs Beth Duvall reviews new transparency meetings that began this m...