Sophiris Bio Inc.developing PRX 302 (topsalysin) for the treatment of symptoms of Benign Prostatic Hyperplasia (BPH, enlarged prostate) and the...
Sophiris Bio a biopharmaceutical company developing PRX 302 (topsalysin) for the treatment of urological diseases, announced final results from its...
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 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.
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 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
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.
Protalix BioTherapeutics, Inc. provided an update regarding the Complete Response Letter (CRL) received from the FDA regarding the Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX 102) for the proposed treatment of adult patients with Fabry disease.
Protalix BioTherapeutics announced positive topline results from its Phase III BRIDGE clinical trial of PRX 102 (pegunigalsidase alfa), the Company's plant cell-expressed recombinant, PEGylated, cross-linked alpha-galactosidase-A product candidate under development for the treatment of Fabry disease.