FDA extends PDUFA for Pegunigalsidase alfa (PRX–102) in Fabry disease
Pegunigalsidase alfa (PRX–102) update : Protalix BioTherapeutics said that the US Food and Drug Administration (FDA) has extended the prescription drug user fee act (PDUFA) date for review of pegunigalsidase alfa (PRX–102) as a treatment of adults with Fabry disease. The PDUFA action date for reviewing the company’s biologics license application (BLA) has been extended […]