The U.S. Food and Drug Administration has issued a Refuse to File (RTF) letter in response to Genzyme’s application for approval of alemtuzumab (Lemtrada) as a treatment for MS. The RTF letter requires that Genzyme reorganize the data presented and resubmit its application. Although no new data are required, the RTF is expected to delay any approval of the drug in MS by at least six months. The drug is currently under review by the European Medic…

…The U.S. Food and Drug Administration has approved the use of oral teriflunomide (Aubagio) 7 or 14 mg/day for the treatment of relapsing forms of MS. The drug was submitted for FDA review in October 2011. The drug has not yet been approved by Health Canada. Subscribe to read more It takes 30 seconds or login using your email address Please enter the email address that you registered the newsletter with Continue…