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Court Upholds State Failure-to-Warn Decision

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A North Carolina federal judge dismisses Novartis post-trial motions seeking to overturn a jury award of damages in a state law fa...

Mylan Warned About Quality Problems at Caguas

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FDAs San Juan District Office warns Mylan Laboratories about CGMP violations at its Caguas, Puerto Rico, drug manufacturing facili...

FDA Clears Canon Radiography Detectors

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FDA clears a Canon USA 510(k) for the CXDI-80C and CXDI-501 Wireless Digital Radiography Detectors.

Merck Settling Vioxx Civil, Criminal Charges for $950 Million

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Merck says it will pay $950 million to resolve federal and state civil and criminal charges involving sales and marketing of its V...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Altaire Pharmaceuticals, Focus Laboratories, Hub Pharmaceuticals, Jenahexal Phar...

Former Synthes Officer Sentenced to 9 Months in Prison

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A federal judge sentences former Synthes chief operating officer Michael Huggins to nine months in jail after pleading guilty to a...

Mylan Settles Suit Over Generic Vivelle-Dot

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Mylan says it has settled patent litigation with Novartis Pharmaceuticals involving a Mylan ANDA for a generic copy of Vivelle-Dot...

Obama Signs FDA 2012 Spending Bill

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President Obama signs into law a spending measure for FY 2012 that gives the agency $2.5 billion or $50 million (2%) more than FY ...

FDA OKs Removal of Bioscan for Spectrum's NHL Treatment

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FDA approves the removal of a bioscan requirement for Non-Hodgkin lymphoma patients receiving Spectrum Pharmaceutical's Zevalin th...

FDA Approves Regeneron BLA for Eylea

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FDA approves a Regeneron BLA for Eylea (aflibercept injection) for treating neovascular age-related macular degeneration.