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FDA approves Nexviazyme® (avalglucosidase alfa-ngpt)

FDA approves Nexviazyme® (avalglucosidase alfa-ngpt)

by CAP | Aug 12, 2021 | News

In a recent announcement, the Pompe disease community learned that the U.S. Food and Drug Administration (FDA) has approved Nexviazyme® for the treatment of late-onset Pompe patients that are one year old and older.

Amicus Therapeutics Has Begun the FDA Submission for Their Pompe Drug, AT-GAA

Amicus Therapeutics Has Begun the FDA Submission for Their Pompe Drug, AT-GAA

by CAP | Dec 3, 2020 | News

Amicus Therapeutics has announced they have begun a rolling Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for their drug combination, AT-GAA, to treat late onset Pompe disease (LOPD).

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