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FDA Approves Merck Januvia sNDA

[ Price : $8.95]

FDA approves a Merck supplemental NDA for expanded labeling on diabetes drug Januvia.

FDA Clears Aperio Technologies HER2 Device

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FDA clears Aperio Technologies HER 2 image analysis application to aid in detecting and quantifying HER2 protein expression.

Advisors Back Phosphate Binder Use

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Members of FDAs Cardiovascular and Renal Drugs Advisory Committee vote 8-4 to recommend using phosphate binders to treat hyperphos...

$4 Million to C-Path for Drug Interactions Research

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HHS awards $4 million to the Critical Path Institute to expand its programs on preventing dangerous drug interactions.

FDA Backs CMS on Use of ESAs

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FDA says Medicares national coverage determination allowing dosing of erythropoiesis-stimulating agents in cancer patients up to 1...

Quality System Problems at EM Probe

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FDAs Seattle District Office warns EM Probe over QS problems in its manufacture of the EM-pulse Trilogy and EM-pulse Solo.

Ortho Biotech Dropping Sporanox Injection

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Ortho Biotech says it is discontinuing Sporanox for injection and expects its warehouse to have distributed all remaining supplies...

FDA Asks Kytril Exclusivity Comment

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Teva says it should be entitled to 180 days market exclusivity for generic Kytril despite expiration of the 30-month period in th...

Troubled Chinese Firm Makes RU-486, Group Says

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Newly released FDA documents on the abortion drug RU-486 disclose officially for the first time that a Chinese pharmaceutical manu...

Academic-Industry Relationships Can Cause Problems

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Researchers writing in the Journal of the American Medical Association say relationships between industry and medical schools are ...