US FDA accepts MS drug Lemtrada resubmission for review

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US FDA accepts MS drug Lemtrada resubmission for review

Post by MSUK » Tue Jun 03, 2014 7:29 am

The US Food and Drug Administration (FDA) has accepted for review the Genzyme's resubmission of supplemental Biologics License Application (sBLA) seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. A six-month review period has been assigned for the Lemtrada sBLA. Genzyme expects FDA action on the sBLA in the fourth quarter...... Read More - http://www.ms-uk.org/lemtrada
MS-UK - http://www.ms-uk.org/

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