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  • Regulatory NewsRegulatory News

    EMA Begins Safety Review of MS Drug Lemtrada

    The European Medicines Agency (EMA) on Friday initiated a review of Sanofi’s multiple sclerosis (MS) drug Lemtrada (alemtuzumab) following new reports of immune-mediated conditions and problems with the heart and blood vessels of those taking the medicine, including deaths. “As a temporary measure while the review is ongoing, Lemtrada should only be started in adults with relapsing-remitting multiple sclerosis that is highly active despite treatment with at least two di...
  • Regulatory NewsRegulatory News

    FDA Warns of Rare but Serious Risks Linked to MS Drug Alemtuzumab

    The US Food and Drug Administration (FDA) on Thursday warned that serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis (MS) shortly after they received Sanofi’s Lemtrada (alemtuzumab). In the nearly five years since FDA approved Lemtrada to treat relapsing forms of MS, the agency said it identified 13 worldwide cases of ischemic and hemorrhagic stroke or arterial dissection that occurred short...