FDA Holds Off Approval of New Merck Drug
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Merck &amp; Co. (MRK.N: Quote, Profile, Research) on Friday said US regulators won&#39;t approve its experimental arthritis drug Arcoxia until the company provides more data showing it is safe and effective.
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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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Merck & Co.MRK.N said on Friday it   has delayed filing for a high-profile combination pill designed   to lower "bad" cholesterol and increase "good" cholesterol,   while heading off a common side effect of one of the   ingredients.
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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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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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Merck &amp; Co., which withdrew the Vioxx painkiller last month because of a heart risk, said yesterday that US regulators have asked for more safety data before they will approve the medicine&#39;s successor, Arcoxia.
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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 the first cholesterol-lowering drug without a prescription.
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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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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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(WASHINGTON) - The maker of a new drug to treat women&#39;s sexual dysfunction says the product is safe and should be approved without delay.
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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 midyear, the company said on Tuesday.
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The approval of a new drug is a long-term opportunity.
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BETHESDA, Md.  - A U.S. advisory panel on Friday  urged regulators to reject over-the-counter sales of Merck &  Co. Inc.'s MRK.N cholesterol-lowering drug Mevacor.
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Yet another delay from the FDA leaves investors hanging.
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U.S. regulators said on Friday they  would review whether to take action over Merck & Co Inc's   and Schering-Plough Corp's  popular cholesterol  medicine Vytorin after a study showed it was no better than a  generic drug in preventing the build-up of fatty plaque.
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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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Momenta announces a delay in the FDA review of its lead drug.