Novartis: FDA Wants More Certican Details
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Swiss drug maker Novartis Pharma AG said Monday that the Food and Drug Administration has again requested more information on the company&#39;s Certican treatment, when used in combination with Neoral, to prevent heart and kidney transplant rejection episodes
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Novartis gets set to market a novel diabetes treatment, with EU approval that is not all it had hoped for.
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Drug makers are worried that calls for greater disclosure of early-stage clinical trials might lead to the release of scientific information that could help competitors, an industry lobbyist said on Monday.
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A congressional subcommittee wants to subpoena criminal investigators at the Food and Drug Administration about their own probe concerning the antibiotic Ketek, which has been linked to liver failure.
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New reports accuse another drug company of being too slow to pull a dangerous medication from the market and question the ability of the US federal Food and Drug Administration to protect Americans from such risks.
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The Food and Drug Administration told Merck &amp; Co. that the company needs to supply more data for its Arcoxia pain treatment to gain approval, the pharmaceutical company said Friday.
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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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The Chiron Corporation said yesterday that it had received a warning letter from the Food and Drug Administration demanding more information about the company&#39;s plans to fix widespread sanitary
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An unsurprising response from the FDA.
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Heart attack prevention has just taken another step with the US Food and Drug Administration&#39;s go-ahead for one of the nation&#39;s best-selling cholesterol
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Patients and parents need more information on cancer risk from topical creams used to treat the skin condition eczema, a U.S. panel of medical experts said on Tuesday.
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A study shows promising results for Novartis's COX-2 inhibitor.
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NEW YORK  - Physicians frequently fail to   provide patients with all the information they should have when   they're prescribed new medication, investigators in California   report.
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Biogen Idec Inc. of Cambridge said it is in final discussions with the Food and Drug Administration about its new multiple sclerosis drug Antegren, and expects the drug to be approved by the end of the month.
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The Food and Drug Administration has sent a warning letter to Novartis Animal Health U.S., Inc. because of what federal officials say were late reports on the death of cats being tested with a new painkilling drug.
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Novartis AG failed to give the government prompt, accurate reports about deaths of dogs treated with a painkiller in the same class of medicines now linked to heart problems in humans, US regulators have charged in a letter.
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The Food and Drug Administration insists that until pharmaceutical giant Merck presented new information this week, there was not enough evidence to pull the arthritis drug Vioxx off the market.