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. […]

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 […]

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 […]

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 […]

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) […]

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, […]

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 […]

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, […]

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, […]