FDA Holds Off Approval of New Merck Drug
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Merck & Co. MRK.N on Friday said  U.S. regulators have decided not to approve the company's  experimental arthritis drug, the successor to its recalled  Vioxx pill, until more safety and effectiveness data are  obtained.
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Two potentially new classes of anti-HIV drugs have the medical world excited. But progress on a vaccine is still slow  -  and drugs can't do everything
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The Food and Drug Administration ignored danger signals from its own scientists about Merck and Co. Inc.&#39;s Vioxx painkiller, Sen. Charles Grassley told a hearing Thursday into the drug&#39;s withdrawal in September.
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The Food and Drug Administration told Merck &#38; Co. that it would approve the company's successor drug to the now defunct pain reliever Vioxx if it provides further safety and efficacy data, the big pharmaceutical company announced Friday.
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The approval of a new drug is a long-term opportunity.
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SILVER SPRING, Maryland  - A U.S. advisory panel urged the government on Thursday to reject Merck & Co Inc's latest bid to sell a cholesterol-lowering drug without a prescription.
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An experimental HIV drug from Merck &amp; Co. Inc. should be quickly approved for use by patients running out of treatment options, federal advisers recommended Wednesday.
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Industry analysts are predicting US regulators this month will refuse to approve Merck &amp; Co.&#39;s new arthritis drug until at least 2006 because of heart attacks linked to its recalled sister drug Vioxx.
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The Food and Drug Administration  ignored danger signals from its own scientists about Merck and  Co. Inc.'s Vioxx painkiller, Sen. Charles Grassley told a  hearing Thursday into the drug's withdrawal in September.
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When Raymond Gilmartin became chairman of the drug maker Merck, it was close to introducing several new medicines. Now, the company is in crisis.
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U.S. health officials said on Friday  they would review whether to take regulatory action over Merck  & Co Inc  and Schering-Plough's  cholesterol  medicine Vytorin following the drug's failure to work better  than a generic drug in a study of plaque build-up in neck  arteries.
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Merck & Co. on Tuesday said it aims to seek U.S. approvals next year for drugs to treat HIV, cholesterol and insomnia and aims to have another four products in late-stage trials by mid-2007.
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The FDA has another delay for this HPV vaccine.
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U.S. health officials said on Friday  they would review whether to take regulatory action over Merck  & Co Inc and Schering-Plough's cholesterol medicine Vytorin  following the drug's failure to work better than a generic drug  in a study of plaque build-up in neck arteries.
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Merck & Co.  expects to seek U.S. approval in 2007 for drugs to treat HIV, cholesterol and insomnia, and aims to have another four products in late-stage trials by mid-year, the company said on Tuesday.
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Merck &amp; Co. said the US Food and Drug Administration has requested additional safety and efficacy information on its Vioxx successor, Arcoxia, before it considers granting US approval for the drug.
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Merck & Co Inc. won U.S. approval for a new drug to treat a rare and slow-growing skin cancer, health officials said on Friday.