Novartis Transplant Drug Certican Delayed by FDA
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Novartis AG, Switzerland&#39;s largest drugmaker, said the US Food and Drug Administration has delayed approval of its Certican transplant treatment and is seeking more information on safe and effective dosing.
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Edwards Lifesciences Corp. EW.N on  Friday said it does not expect the U.S. Food and Drug  Administration to provide an answer on whether it can conduct a  clinical trial on its percutaneous aortic valve replacement  before the end of the year.
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WALL STREET analysts last night said a second experimental pain killer under development by Merck, the American drugs maker, could be delayed until 2007, after regulators asked for more information on the medicineâs safety.
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NEW YORK - In a capstone to the withdrawal of Vioxx, the US Food and Drug Administration has decided to delay the approval of successor drug Arcoxia until more safety data are available.
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LONDON, October 6  - AstraZeneca (AZN.ISE) has delayed the regulatory approval filing target for its diabetes drug, Galida, from 2006 to 2007, while admitting that its anti-blood clotting drug, Exanta, was unlikely to receive the US
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A Canadian company's cheap generic version of the blood thinner Plavix has been blocked from the U.S. market until at least 2011.
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The Swiss pharmaceutical group Novartis withdrew on Tuesday an application for EU approval of a new arthritis drug called Prexige to await a review of such treatments next year.
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The FDA has another delay for this HPV vaccine.
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BOSTON (CBS.MW) - Shares of Genentech were halted on Monday as the company announced that its oncology drug Avastin had been shown to extend the lives of some patients stricken with advanced colorectal cancer.
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AstraZeneca Plc (AZN) on Friday said US regulators did not approve its anti-clotting drug Exanta. The US Food and Drug Administration followed the advice of an advisory panel, which last
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U.S. regulators need more clinical trials before they can approve heart-scan contrast agent MS-325 from Germany's Schering and U.S. partner Epix Pharmaceuticals, the companies said on Friday.
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Johnson &amp; Johnson will delay by five months the release of a study comparing its Cypher heart device with Boston Scientific Corp.'s Taxus, the first large-scale comparison of the only two drug-coated stents on the market.
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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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Emeryville&#39;s Chiron Corp. said Thursday that it will delay shipments until early October of its flu vaccine, Fluvirin, after the company identified a small number of lots that do not meet product sterility specifications.
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U.S. regulators have asked for more data on Novartis AG's  diabetes drug Galvus, possibly delaying approval of the potential blockbuster by a year, which dented its shares while boosting its main rival's.
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Manufacturers of unapproved extended-release cough and cold drugs that contain an expectorant called guaifenesin have until Nov. 25 to stop shipping the medications, health officials said yesterday.
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Drug maker AstraZeneca PLC said Friday that the Food and Drug Administration did not approve its orally taken blood thinner Exanta.