FDA Approves Portola Pharmaceuticals' Prior Approval Supplement for Andexxa Generation 2 Manufacturing Process

2019-01-08 10:06:04 Itn

The U.S. Food and Drug Administration (FDA) has approved Portola Pharmaceuticals’ Prior Approval Supplement (PAS) for its large-scale, second generation Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo], allowing for broad commercial launch in the United States.

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