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relapsing multiple sclerosis
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FDA Has Accepted Genzyme Lemtrada (Alemtuzumab) Biologics License Application for RMS
Jan 30, 2013The US FDA has accepted Genzyme Lemtrada (alemtuzumab) biologics license application (sBLA) for review for relapsing multiple sclerosis (RMS). Genzyme also reported encouraging early US launch indicators for Aubagio (teriflunomide) such ...
Tags: FDA, biologics license application, relapsing multiple sclerosis
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Genzyme Submitted a Supplemental Biologics License Application
Dec 5, 2012Genzyme, a Sanofi company, has submitted a supplemental biologics license application (sBLA) to the FDA and marketing authorization application (MAA) to EMA for Lemtrada to treat relapsing multiple sclerosis (RMS). In collaboration with ...
Tags: sBLA, relapsing multiple sclerosis, RMS
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Genzyme Multiple Sclerosis Medication Gets Approval in Australia
Nov 27, 2012Australian Therapeutic Goods Administration (TGA) has cleared Genzyme's once daily oral Aubagio 14mg dose for the treatment of relapsing multiple sclerosis (MS). Aubagio, which has anti-inflammatory properties, is expected to minimize ...
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Genzyme Received a Refuse to File Letter From The US Food and Drug Administration
Aug 27, 2012Genzyme, a Sanofi company, has received a refuse to file letter from the US Food and Drug Administration (FDA) in response to the supplemental Biologics License Application (sBLA) for the approval of Lemtrada (alemtuzumab) as a treatment ...
Tags: Genzyme, Lemtrada marketing, FDA
