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The US Food and Drug Administration has approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) under its priority review program. The agency reviewed and approved the drug ahead of the April 18th goal date.
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Researchers have developed a new method of restoring antibiotic sensitivity to resistant bacteria.
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If approved, FDA would charge pharmaceutical manufacturers application fees for reviewing traditional drugs, generic drugs, and a new class of generic biotech drugs.
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Presented here is a synopsis of Pradaxa vs. Warfarin views and a link to a cardiac specific article that presents a more detailed discussion that provides cardiac patients a clearer understanding of whether they should worry about whether they are taking Pradaxa over Warfarin.
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Check your medicine cabinet for Excedrin, Bufferin, NoDoz, and Gas-X--they have been recalled by Novartis.
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Two rotavirus vaccines re-introduced during that last five years are showing no serious side affects as did the original verison banned in 1999.
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A new analysis suggests the FDA may have been premature in placing a warning for testing patients for the effectiveness of Plavix, a drug that prevents blood clots after stenting or coronary artery interventions. People with a genetic variant of a liver enzyme may not metabolize the medication properly, prompting the FDA to recommend genotyping, which is now under scrutiny.
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The Partnership for Safe Medicines has issued a warning about fake generic Lipitor that will soon be available. The cholesterol lowering drug was approved by the FDA in generic form in November.
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Imagine a world without antibiotics. Centuries ago, there were no synthetic antibiotics, and that day may come again soon unless there is an investment in developing new antimicrobials, given that a growing number of people are becoming resistant to the currently available options.
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The US Food and Drug Administration (FDA) has released a report entitled “FY2011 Innovative Drug Approvals” highlighting the accomplishments of the agency this fiscal year which ended on September 30. Thirty-five new medications for diseases including hepatitis C, prostate cancer, Hodgkin’s lymphoma and lupus have been approved, many ahead of other countries.
