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April 7, 2014
05:28 EDTSNYGenzyme to resubmit Lemtrada application for FDA review
Genzyme, a Sanofi company, announced that following constructive discussions with the FDA the company plans to resubmit in the second quarter its supplemental Biologics License Application, or sBLA, seeking approval of Lemtrada for the treatment of relapsing forms of multiple sclerosis. The resubmission will provide information to specifically address issues previously noted by the FDA in its December 27, 2013 Complete Response Letter. Genzyme had previously announced its intention to appeal the FDAs Complete Response Letter. In light of the planned resubmission, the company does not expect to pursue an appeal at this time.
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December 9, 2014
11:19 EDTSNYSanofi reportedly ready to make acquisitions in animal medicine, Bloomberg says
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