August 24, 2009
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FDA’s Early Communication about the Ongoing Safety Review of Orlistat. FDA is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat. […]
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November 11, 2008
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Agency Investigating Dilantin Risks of SJS and TEN FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson […]
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March 24, 2006
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Biogen Idec and Elan announced on March 22, 2006, that the Food and Drug Administration (FDA) had extended the regulatory review period for the reintroduction of […]
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February 15, 2006
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Why is FDA lifting the clinical hold? We received detailed information on the extensive re-examination that Biogen and Elan undertook on all patients who had received […]
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December 8, 2005
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The FDA (Food and Drug Administration) issued a Public Health Advisory in December of 2005 that warned doctors and patients of the potential for Paxil (paroxetine) […]
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March 1, 2005
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What is Tysabri? Tysabri is a monoclonal antibody that binds to a protein called alpha-4-integrin. Integrins are found primarily on the surface of white blood cells, […]
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November 23, 2004
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First Monoclonal Antibody Treatment For Multiple Sclerosis Approved FDA today licensed a new biologic approach to treat patients with relapsing forms of multiple sclerosis (MS) to […]
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November 23, 2004
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What is natalizumab? Natalizumab is a monoclonal antibody that binds to a protein called alpha-4-integrin. Integrins are found primarily on the surface of white blood cells, […]
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November 23, 2004
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What is Tysabri? Tysabri is a monoclonal antibody that binds to a protein called alpha-4-integrin. Integrins are found primarily on the surface of white blood cells, […]
Do you like it?