The European Medicines Agency has restricted the use of Zinbryta (daclizumab) for relapsing multiple sclerosis after reports of patients experiencing severe liver damage and one dying of liver disease.
The ... Read more
American patient groups and neurologists have clearly been giving Ocrevus (ocrelizumab) plenty of attention since news of its approval landed, as a sweep of U.S. reaction to the FDA’s decision showed. ... Read more
Merck KGaA, Darmstadt, Germany recently announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) of the company’s investigational product Cladribine Tablets as a therapy for relapsing ... Read more
The U.S. Food and Drug Administration (FDA) is giving priority review to a request to approve Ocrevus (ocrelizumab) as a treatment for both forms of multiple sclerosis, the drug’s developer, Genentech, announced. If ... Read more
Biogen, announced that TYSABRI, a drug developed to treat people with multiple sclerosis (MS) has received a positive opinion from the European Medicine Agency (EMA) recommending its approval to ... Read more
The European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC), responsible for assessing and monitoring safety issues for human medicines, completed a review on the risk for progressive multifocal leukoencephalopathy (PML) ... Read more