Approval Process Stalls on Female Sex Drug
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WASHINGTON Dec 2, 2004 - A hormone patch that works to restore a woman&#39;s sex drive should not be approved until additional studies to determine its risk, federal health advisers said Thursday.
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Clinical trials of a new microbicide gel designed to help prevent women contracting HIV are stopped.
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Almost one-fifth of the Food and Drug Administration scientists surveyed two years ago as part of an official review said they had been pressured to recommend approval of a new drug despite
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Merck & Co.  said on Friday it  would delay seeking approval for a combination pill designed to  lower "bad" cholesterol, increase "good" cholesterol and avoid  a common side effect of one of the ingredients.
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Many women, both surgically and naturally menopausal, probably were disappointed last week when a Food and Drug Administration advisory group recommended holding off approving a new libido patch to rev up womenâs low sex desire.
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WASHINGTON &#151; When federal regulators delayed approving a promising new prostate cancer therapy, patients and the drug&#146;s advocates reacted with more than disappointment.
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Genentech said that approval of its colon cancer drug Avastin as a treatment for breast cancer would be delayed by at least a year.
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GlaxoSmithKline Plc's cervical cancer vaccine Cervarix faces a delay in winning approval in the United States, putting it further behind Merck & Co Inc's rival product Gardasil.
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The first drug to treat female sexual dysfunction isn&#39;t ready for the market yet because of safety concerns, a federal advisory committee cautioned Thursday.
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An advisory panel recommends approval of a new HIV drug that blocks one key element.
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[LUSAKA] Africa&#39;s scientific community should develop standards to guide research on microbicides - substances that kill or block the HIV virus â-aid participants at a meeting on vaginal microbicides held last week (17-19 November) by the Southern
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Nearly 20 percent of U.S. Food and  Drug Administration scientists surveyed in late 2002 said they  were pressured to approve or recommend approval of a medicine  despite their reservations about the drug's risks or  effectiveness, according to documents made public on Thursday.
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Federal health advisers say there&#39;s not enough information to make sure a hormone patch that revives women&#39;s libido is safe for long-term use.
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The first anti-AIDS vaginal gel to make it through late-stage testing failed to stop HIV infection in a study of 6,000 South African women, disappointed researchers announced Monday.
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Staff members of the Food and Drug Administration on Wednesday issued a report raising several questions about an experimental drug from Procter &amp; Gamble (PG:NYSE - news - research) designed to improve sexual desire in women whose ovaries have been
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-- A hormone patch that works to restore a woman&#39;s sex drive should not win government approval until more studies are completed to determine the drug&#39;s risks, federal health advisers recommended Thursday.
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Lyle E. Craker&#39;s plans to grow marijuana in his University of Massachusetts laboratory to be used for medicinal studies have been put on indefinite hold by the US Drug Enforcement Administration.