by United Pompe | Jan 18, 2016 | News
Date: July 29, 2005 Pivotal Trial Meets Primary Endpoint Genzyme Corp. (Nasdaq: GENZ) announced today that it has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration for Myozyme® (alglucosidase alfa). If approved, Myozyme would be...
by United Pompe | Jan 18, 2016 | News
Pompe Program Update July 2005 Steady progress is being made in all areas of the Genzyme Pompe program and the goal of obtaining worldwide regulatory approval for the investigational rhGAA enzyme remains one of Genzyme’s highest priorities. The screening...
by United Pompe | Jan 18, 2016 | News
Pompe Program Update December 2004 Genzyme is still on track for the Marketing Authorisation Application (MAA) filing in December with the European regulatory authorities, and they will issue a corporate press release once the filing has been formally accepted....
by United Pompe | Jan 18, 2016 | News
Genzyme Files for European Approval of Myozyme For Treatment of Pompe Disease Date: December 20, 2004 Genzyme Corp. (Nasdaq: GENZ) announced today that the European Medicines Agency (EMEA) has accepted its marketing authorization application for Myozyme...
by United Pompe | Jan 18, 2016 | News
Genzyme Pompe Program Update May 2004 Genzyme’s Pompe Program has progressed on many fronts over the last 6 months, and we are optimistic that the development of rhGAA will continue to proceed rapidly and responsibly. Infantile Onset Genzyme has two...
by United Pompe | Jan 18, 2016 | News
IPA /Genzyme Joint Pompe Program Update, August 2004 Infantile-Onset Expanded Access Program Enrollment in the Infantile Expanded Access Program is currently on-going. Physicians who may have an infantile-onset Pompe patient should contact Genzyme Medical...
