Remel Xpect Flu A&B granted FDA clearance

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TweetThermo Fisher Scientific, Inc., announced on Monday that its Remel Xpect Flu A&B assay was granted clearance by the FDA for assessing detection of emerging viruses. The Remel Xpect Flu A&B assay is currently able to find culture avian influenza … Read More »

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BD supports proposal by FDA to reclassify rapid flu tests

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TweetBecton, Dickinson and Company, a global medical technology company, recently announced its support for the U.S. Food and Drug Administration’s proposed reclassification of rapid influenza detection tests. The 2009 flu pandemic demonstrated the poor performance of available point-of-care flu tests. … Read More »

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FDA announces results of investigation into cyclospora outbreak

Cyclospora cayetanensis

Tweet The U.S. Food and Drug Administration collaborated with the Mexican government and authorities of Taylor Farms de Mexico to conduct a thorough investigation of a Cyclospora outbreak in Iowa and Nebraska. The outbreak began this summer; the last known … Read More »

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FDA approves marketing for system that tests yeasts and bacteria

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TweetThe U.S. Food and Drug Administration announced on Wednesday that it will allow U.S. marketing of the first mass spectrometer system that automatically identifies illness-causing bacteria and yeasts. The VITEK MS is able to identify 193 different microorganisms and can … Read More »

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Additional GSK quadrivalent flu vaccine approved by FDA

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TweetGlaxoSmithKline plc, a research-based pharmaceutical company, recently announced the U.S. Food and Drug Administration’s approval of GSK’s FluLaval Quadrivalent influenza virus vaccine for individuals three years of age and older. The vaccine is the second GSK intramuscular quadrivalent influenza vaccine … Read More »

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FDA issues update on multi-state cyclosporiasis outbreak

Cyclospora cayetanensis

Tweet The U.S. Food and Drug Administration reported on Monday that a company implicated in the multi-state outbreak of cyclosporiasis voluntarily suspended production of its products until it receives approval from the FDA. On Friday, Taylor Farms de Mexico voluntarily … Read More »

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FDA approves new drug for HIV treatment

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Tweet The U.S. Food and Drug Administration approved a new drug to treat HIV-1 infection on Monday that be taken daily in combination with other antiretroviral drugs. Tivicay, which is also known as dolutegravir, is an integrase strand transfer inhibitor … Read More »

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FDA approves test that detects HIV antibodies

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Tweet The U.S. Food and Drug Administration announced on Thursday that is has approved the first rapid detection test for Human Immunodeficiency Virus. The Alere Determine HIV-1/2 Ag/Ab Combo test is used to detect HIV-1 p24 antigen as well as … Read More »

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Researchers find CDC underestimated antibiotic resistance of infections

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Egg-free vaccine receives FDA approval for distribution

House Republicans threaten to subpoena FDA over meningitis outbreak

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Tamiflu approved for children as young as two weeks old

FDA approves new seasonal influenza vaccine

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Researchers develop vaccine for leishmaniasis

FDA say new TB treatment appears safe and effective

FDA’s role in meningitis outbreak examined

FDA discusses REMS during webinar

House holds contentious hearing with FDA commissioner