by United Pompe | Jan 18, 2016 | News
Genzyme Pompe Program Update- November 17, 2008 We would like to take this opportunity to provide an important update to the Pompe Community. The US Food and Drug Administration (FDA) has informed Genzyme that the FDA plans an accelerated approval for...
by United Pompe | Jan 18, 2016 | News
Myozyme Produced at the 2000 L Bioreactor Scale to Receive Accelerated Approval Date: November 17, 2008 New PDUFA Date Set for February 28, 2009 Genzyme Corporation (Nasdaq: GENZ) today announced that the FDA plans an Accelerated Approval for Myozyme® (alglucosidase...
by United Pompe | Jan 18, 2016 | News
Amicus Therapeutics Begins Phase 2 Clinical Trial of AT2220 in Pompe Disease
by United Pompe | Jan 18, 2016 | News
Amicus Therapeutics Presents Data from Clinical Ex Vivo Response Study
by United Pompe | Jan 18, 2016 | News
January 2008 US Myozyme Supply Update In April 2007, Genzyme implemented measures to manage the limited supply of Myozyme® (alglucosidase alfa) in the United States in order to ensure uninterrupted treatment for as many patients as possible. Since April, both the...
by United Pompe | Jan 18, 2016 | News
Amicus Therapeutics and Shire plc Enter Into $440 Million ex-US Licensing Agreement