RE FDA REJECTS M.S DRUG WITH POTENTIALLY SERIOUS SIDE EFFCT
Posted: Tue Mar 01, 2016 2:08 am
Seva, please, please please copy and quote the first few paragraphs with any link you provide. Doing so may of highlighted that this report is actually from 2014. Lemtrada is not only approved in Australia, but it is also on the PBS (public funding)
FDA Rejects MS Drug with Potentially Serious Side Effects
Written by Jeri Burtchell | Published on January 8, 2014
Genzyme's MS drug Lemtrada falls short of FDA requirements.
Drugmaker Genzyme was dealt a major blow last week when its multiple sclerosis (MS) drug Lemtrada was rejected by the Food and Drug Administration (FDA). The FDA ruling cited the need for further trials to demonstrate the drug's effectiveness and safety. European regulators approved Lemtrada in September 2013.