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Sanofi Pasteur Files sBLA for Quadrivalent Fluzone

[ Price : $8.95]

Sanofi Pasteur files a supplemental BLA with FDA for a quadrivalent formulation of its Fluzone (influenza virus vaccine).

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...

FDA Study Sees Higher Risk in Some Birth Control Pills

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An FDA-funded study finds an increased risk for thromboembolic events in women who use drospirenone-containing birth control pills...