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FDA OKs Aurobindos Generic Zoloft

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FDA approves an Aurobindo Pharma ANDA for a generic copy of Pfizers Zoloft.

Genentech/OSI Pharma Mull New Tarceva Indication

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Genentech and OSI Pharmaceuticals say they are considering seeking a new indication for Tarceva (erlotinib) after new study data s...

Waxman and Dingell Joust on FDA Oversight

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Reps. Waxman and Dingell, both of whom have been vocal critics of FDA, are running to be chairman of the powerful House Energy and...

Faster Pace Needed on Personalized Medicine

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The Presidents Council of Advisors on Science and Technology says FDA needs to step up its approach to regulating genomics-based m...

Nidek, Doctors et al Sued for FDA-unapproved Lasik

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A California lawyer files a federal class action suit against Japan-based ophthalmic laser maker Nidek, physicians and surgical fa...

Teva Loses Bid for Early Launch on Generic Prevacid

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The U.S. Court of Appeals for the Federal Circuit affirms a lower court ruling against a Teva bid to launch a generic copy of TAP'...

Former FDA Top Lawyer Touts Lassman as Next Chief Counsel

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Former FDA chief counsel Sheldon Bradshaw endorses WilmerHale partner Scott Lassman as the agencys next top lawyer.

Harvards Blumenthal on FDA Commish Short List

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Various news outlets list Harvard professor David Blumenthal as a possible candidate for FDA commissioner under the Obama administ...

Sanofi-Aventis, Pfizer End Diet Drug Development

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Sanofi-Aventis and Pfizer say they are halting development of two weight-loss drugs due to shifting regulatory requirements.

Tropical Diseases Hearing

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Federal Register Notice: FDA plans a public hearing to obtain comments on additional diseases added to the list of tropical diseas...