After constructive talks with the U.S. Food and Drug Administration or FDA, Sanofi's unit, Genzyme, plans to resubmit in the second quarter its supplemental Biologics License Application or sBLA seeking approval of Lemtrada to treat relapsing forms of multiple sclerosis. The resubmission would provide information to specifically address issues noted by the FDA in its December 27, 2013 Complete Response Letter.
Earlier, Genzyme intended to appeal the FDA's Complete Response Letter. Considering the planned resubmission, the company does not anticipate to pursue an appeal at this time.
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May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.