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FDA Releases 37 Labeling Changes

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FDA releases labeling changes approved in September for 37 drugs.

Risk Info Added to Invirase Labeling

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FDA changes labeling for Genentechs Invirase to add information on a potential change in heart electrical activity when it is used...

Protege Trial Fails to Meet Endpoint

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MacroGenics and Lilly end trials of Protege after it fails to meet efficacy endpoints in a Phase 3 Type 1 diabetes study.

Neoprobe Sends FDA RIGScan BLA Response Letter

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Neoprobe says it has sent a RIGScan BLA response letter to FDA as the first of several planned steps in reactivating the applicati...

FDA Finds High Peroxide Levels in Crospovidone Lot

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FDA says it has detected high levels of peroxide in one lot of Crospovidone manufactured by a Chinese firm.

FDA Approves Boehringer's Warfarin Replacement

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FDA approves a Boehringer Ingelheim Pharmaceuticals NDA for Pradaxa capsules (dabigatran etexilate) for preventing stroke and bloo...

FDA Asks for More Bydureon Info

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An FDA complete response letter asks for a QT study and other information on Amylins NDA for its Type 2 diabetes drug Bydureon.

Aastrom Submits SPA for Critical Limb Ischemia Program

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Aastrom Bioscience submits an SPA to FDA for a Phase 3 clinical development program in critical limb ischemia.

Class 1 Drug Recalls Skyrocket This Year

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CDER recall stats show Class 1 drug recalls this year are on track to almost exceed totals of the last three years combined.

FDA Science Board Nominees Sought

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Federal Register Notice: FDA requests nominations for voting members industry to serve on the Science Board to FDA.