FDA staff questions Sanofi bird flu vaccine
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Data on Sanofi-Aventis's    experimental bird flu vaccine shows higher doses  worked better, but it is unclear whether those results prove  the product's effectiveness, U.S. regulatory staff said in  documents released on Monday.
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A Food and Drug Administration advisory panel unanimously agreed yesterday that MedImmune's nasal flu vaccine FluMist worked in children under age 5, but it had a decidedly mixed opinion on whether the product was safe enough for children younger than 2.
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The nation's first vaccine against bird flu is even less effective than previously thought, according to Food and Drug Administration documents released Monday.
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The World Health Organization has invited Sanofi-Aventis SA, the world&#39;s biggest maker of flu vaccine, and 15 other companies to join government health officials in planning how to produce
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An internal survey of Food and Drug Administration scientists conducted by the Health and Human Services Office of the Inspector General revealed safety concerns about the FDAâs approval process and monitoring of marketed drugs, according to a press
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GAITHERSBURG, Maryland  - Data for Sanofi-Aventis' experimental bird flu vaccine support its safety and effectiveness for use in the event of a widespread outbreak, a U.S. advisory panel said on Tuesday.
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U.S. Food and Drug Administration staff reviewers on Tuesday questioned clinical data for non-Hodgkin's lymphoma drug Marqibo, made by Inex Pharmaceuticals Corp. and Enzon Pharmaceuticals Inc..
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Federal advisers who met last week to consider whether to restrict doses of popular antianemia drugs were themselves under scrutiny during the hearing. The Food and Drug Administration is considering a top-to-bottom reshaping of how it picks and uses the outside scientists who serve on the agency's advisory panels.
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The US government on Tuesday awarded Sanofi-Aventis (SASY.PA: Quote, Profile, Research) a contract worth up to $41 million through 2008 to ensure that enough eggs are available for future flu vaccine production.
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The Food and Drug Administration has demanded more answers from Chiron Corp. about its efforts to correct operating flaws at the Liverpool plant, where half of the US flu vaccine for this winter was lost to contamination.
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Congress started an investigation on Tuesday into whether the U.S. Food and Drug Administration overlooked problems at a British plant that led to the withdrawal of half the country's flu vaccine supply.
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A team from the Food and Drug Administration met British regulators about their decision to quarantine nearly half the United States' supply of flu vaccine.
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A leading doctor is questioning the government's approach over offering routine flu jabs for children under two.
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The World Health Organization is urging drugmakers including GlaxoSmithKline Plc, Sanofi-Aventis SA and Chiron Corp. to join in developing a vaccine to stop Asia&#39;s deadly bird flu virus from triggering a pandemic.
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Drug companies will not be able to make enough vaccine to prevent the next global flu pandemic, which health officials fear may be triggered by a viral strain originating in birds, a senior World Health Organisation official said today.
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WASHINGTON - The Food and Drug Administration is unlikely to clear influenza vaccine made by Chiron Corp. as safe for Americans to use this flu season, Dr...
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WASHINGTON -- The Food and Drug Administration, seeking to ease a major shortage of flu shots, is in discussions with two companies that sell flu vaccine in Canada and elsewhere, and have found a few million unsold doses.