Genzyme to Resubmit Lemtrada Application for FDA Review
Sanofi and Genzyme to resubmit FDA application for approval of Lemtrada, for the treatment of relapsing forms of multiple sclerosis.
Sanofi and its subsidiary Genzyme reported that the company plans to resubmit its supplemental Biologics License Application (sBLA) seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. The resubmission will provide information to specifically address issues noted by the FDA in its Dec. 27, 2013 Complete Response Letter.
Genzyme had previously announced its intention to appeal the FDA's Complete Response Letter. As a result of the planned resubmission, the company does not expect to pursue an appeal at this time.
Source: Sanofi
Texas' MD Anderson Cancer Center Creates New Cell Therapy Institute
November 11th 2024With the launch of the Institute for Cell Therapy Discovery and Innovation, the MD Anderson Cancer Center will bring together expertise in developing cell therapies for cancer, autoimmune diseases, and infections.
