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Tysabri News

When Insurers Restrict MS Drug Coverage, Relapses Rise

TUESDAY, Aug. 5, 2025 — Multiple sclerosis (MS) patients might have a higher risk of relapse if their health insurance is stingy with prescriptions, a new study reports. Patients with insurance plans ...

Adverse Outcomes Seen With MS Disease-Modifying Drugs in Pregnancy

THURSDAY, Jan. 2, 2025 – Disease-modifying therapy (DMT) use for multiple sclerosis (MS) in pregnancy is associated with certain adverse outcomes, including small for gestational age, according to a...

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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