News Releases

Results from Two Phase III Studies Added to U.S. Label of Genzyme’s Aubagio
Genzyme, a Sanofi company, announced today that the Food and Drug Administration (FDA) has approved the inclusion of efficacy and safety data from the TOWER and TOPIC studies of once-daily, oral Aubagio® (teriflunomide) in the product’s U.S. label.
Lemtrada Fails to Win Approval from FDA for MS Rx
A new multiple sclerosis medication has failed to win FDA approval.
Multiple Sclerosis Rx Approved by FDA
EMD Serono , Inc., a subsidiary of Merck KGaA , Darmstadt , Germany, and Pfizer Inc. announced today that the US Food and Drug Administration (FDA) approved Rebif ® Rebidose ® (interferon beta-1a ), a single-use auto-injector for the self-administration of Rebif , a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS).
Genzyme Applies for Approval of Lemtrada
Genzyme , a Sanofi company announced that the company has submitted a supplemental Biologics License Application ( sBLA ) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application ( MAA ) to the European Medicines Agency ( EMA ) seeking approval of LEMTRADA ( alemtuzumab ) for treatment of relapsing multiple sclerosis ( RMS ).
Ocrelizumab Maintained Significant Reduction in Muliple Sclerosis
Roche announced 96-week results from a Phase II study of ocrelizumab in patients with relapsing-remitting multiple sclerosis (RRMS), the most common clinical form of the disease. Phase III trials underway to investigate ocrelizumab in two forms of MS.