FDA Reports

February 15, 2006

Tysabri Q&A Regarding Lifting of the Clinical Hold

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 […]
December 8, 2005

Paxil Birth Defect Lawsuit

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) […]
March 1, 2005

Tysabri (natalizumab) Questions and Answers

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, […]
February 28, 2005

FDA Issues Warning on Tysabri, a New Drug for MS

The Food and Drug Administration (FDA) today issued a public health advisory to inform patients and health care providers about the suspended marketing of Tysabri (nataluzimab) […]
February 28, 2005

Suspended Marketing of Tysabri (natalizumab): Link to PML

FDA is issuing this public health advisory to inform patients and health care providers about the suspended marketing of Tysabri (natalizumab) due to two serious adverse […]
November 23, 2004

Tysabri Approved by the FDA for Multiple Sclerosis

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 […]
November 23, 2004

Questions and Answers on Natalizumab

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, […]
November 23, 2004

Questions and Answers on Tysabri

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, […]