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LUMIZYME APPROVAL

US Pompe Program Update – December 3, 2009 Genzyme would like to provide an update to the US Pompe community about the status of the Alglucosidase Alfa Temporary Access Program (ATAP) and the application for Lumizyme™ (alglucosidase alfa) approval in the United...

US Pompe Program Update - November 16, 2009

Pompe Program Update – May 22, 2009 Genzyme would like to take this opportunity to provide an important update to the Pompe Community. Background In February 2009, Genzyme received a Complete Response letter from the FDA in regards to the Biologics License Application...

HOME ADAPTIONS FOR SAFETY AND ACCESSIBILITY

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...

Genzyme Receives Complete Response Letter from FDA

MYOZYME® (2000 L) SUPPLY UPDATE US VERSION JANUARY 2009

  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...

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...