by United Pompe | Jan 18, 2016 | News
LZ-US-P022-03-09 Pompe Program Update March 2, 2009 Supply Update In January 2009, Genzyme notified the Pompe community that we were experiencing a temporary constraint in the global supply of Myozyme® (alglucosidase alfa) produced at the 2000 L bioreactor scale and...
by United Pompe | Jan 18, 2016 | News
Genzyme Receives Complete Response Letter from FDA
by United Pompe | Jan 18, 2016 | News
MYOZYME® (2000 L) SUPPLY UPDATE US VERSION JANUARY 2009
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...
