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Tysabri News
Updated FDA Labeling Recommendations for Biosimilar and Interchangeable Biosimilar Products
October 26, 2023 – Over the last eight years, FDA has approved more than 40 biosimilar products (biosimilars), and they have become an important treatment option for health care professionals and...
FDA Approves Tyruko (natalizumab-sztn), a Biosimilar to Tysabri
August 24, 2023 – The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing...
FDA Medwatch Alert: Tysabri (natalizumab): Drug Safety Communication - New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML)
ISSUE: FDA notified healthcare profesisonals that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML). PML is...
FDA Medwatch Alert: Tysabri (natalizumab): Update of Healthcare Professional Information
[UPDATED Posted 04/22/2011] FDA has updated the Tysabri (natalizumab) Prescribing Information to give new information about the size of the risk of progressive multifocal leukoencephalopathy (PML), a...
FDA Medwatch Alert: Tysabri (natalizumab) - Aug 25, 2008
[Posted 08/25/2008] FDA informed healthcare professionals of two new cases of progressive multifocal leukoencephalopathy (PML) in European patients receiving Tysabri monotherapy for multiple...
FDA Medwatch Alert: Tysabri (natalizumab - Feb 27, 2008
[Posted 02/27/2008] Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total...
FDA Medwatch Alert: Tysabri (natalizumab) - Jun 5, 2006
[UPDATE 07/21/2006] Dear Healthcare Provider Letter issued. [Posted 06/05/2006] FDA notified healthcare professionals of the resumed marketing, with a special restricted distribution program of...
FDA Medwatch Alert: Tysabri (natalizumab) - Feb 2, 2005
[02/28/2005] FDA issued a public health advisory to inform patients and health care providers about the suspended marketing of Tysabri (natalizumab) due to two serious adverse events reported with...
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