Chiesi Group and Protalix BioTherapeutics announced that the European Commission has granted marketing authorization to PRX 102 (pegunigalsidase alfa) in the European Union for the treatment of adult patients with Fabry disease.
Protalix BioTherapeutics announced that the FDA has accepted the resubmitted Biologics License Application (BLA) for PRX 102 (pegunigalsidase alfa) for the proposed treatment of adult patients with Fabry disease
Protalix BioTherapeutics and Chiesi Global Rare Diseases announced the submission of a Marketing Authorization Application (MAA) via centralized procedure to the European Medicines Agency (EMA) for PRX 102 (pegunigalsidase alfa) for the proposed treatment of adults with Fabry disease, and the subsequent validation of the MAA by the EMA.
Protalix BioTherapeutics announced positive 12-month on-treatment data from the first 16 out of the 22 adult patients with Fabry disease...
BioTherapeutics and Chiesi announced final results from the BRIGHT Phase III clinical trial evaluating PRX 102 (pegunigalsidase alfa) for the potential treatment of Fabry disease.
Sophiris Bio a biopharmaceutical company developing PRX 302 (topsalysin) for the treatment of urological diseases, announced final results from its...
Protalix BioTherapeutics and Chiesi Global Rare Diseases announced final study results from the BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating PRX 102 (pegunigalsidase alfa) for the treatment of Fabry Disease.
Protalix BioTherapeutics and Chiesi Global Rare Diseases announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company's Biologics License Application (BLA) seeking accelerated approval of PRX 102 (pegunigalsidase alfa) for the proposed treatment of adult patients with Fabry disease.