US FDA to Sanofi/Genzyme: Get organized on Lemtrada application
This article was originally published in Scrip
Genzyme's US supplemental biologics license application (sBLA) for Lemtrada (alemtuzumab) as a treatment for relapsing multiple sclerosis hit some rough waters at the US FDA, which told the Sanofi subsidiary to reorganize its sBLA so regulators could better navigate it.
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