Tag Archives: Food and Drug Administration

New painkiller ‘Zohydro’ raises more questions than answers

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A consortium of health professionals, law enforcement officials, and addiction specialists is calling on the Food and Drug Administration to stop a new drug called Zohydro due its risks.Zohydro, a...

What Is The ‘Yoga Mat’ Chemical And Why Is It In Your Food?

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The “yoga mat” chemical softener officially known azodicarbonamide hit the headlines last week when Subway announced they were dropping the ingredient from their sandwiches. But chances are, you’re...

FDA, Michelle Obama Team Up To Overhaul Nutrition Labels

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The FDA is proposing a major overhaul to nutrition labels, to make them more user-friendly and reflective of the latest nutrition science. The new labels will include information about added sugars...

Johnson & Johnson Shares Clinical Trial Data

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In a major victory for advocates of open access to data from clinical trials, Johnson & Johnson today announced that it will make all of its clinical trial data available to outside researchers....

FDA Grants Earlier Than Expected Approval For Medtronic’s CoreValve

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The FDA today approved Medtronic’s CoreValve transcatheter aortic valve replacement (TAVR) system for patients with severe aortic stenosis who are unable to undergo conventional open-heart surgery....
    






Acetaminophen Warning

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It was only recently that some of the dire consequences of taking overdoses of OTC drugs were examined by the FDA. In particular, acetaminophen which is found in such over the counter medicines as...
    






FDA Panel Once Again Rejects New Indication For J&J Drug

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The FDA’s Cardiovascular and Renal Drugs Advisory Committee once again turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson & Johnson’s Xarelto...
    






FDA Advisory Panel Votes In Favor Of Approval For Merck’s Vorapaxar

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The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-1 in favor of approval for vorapaxar, Merck's novel thrombin receptor antagonist. The “roller coaster ride” cliché might have...
    






Johnson & Johnson Faces Uphill Battle At FDA Advisory Panel

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The third time may not be the charm. Twice before the FDA has turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson & Johnson’s Xarelto (...
    






Merck’s Vorapaxar Gets Positive FDA Review

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A few years ago a novel antiplatelet agent from Merck seemed all but dead. Vorapaxar, a thrombin receptor antagonist, was widely thought to have no future after unacceptably high serious bleeding...