Diana Campelo Delgado,  —

Diana holds a PhD in Biomedical Sciences, with specialization in genetics, from Universidade Nova de Lisboa, Portugal. Her work has been focused on enzyme function, human genetics and drug metabolism.

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FDA Extends Review Date to April for US Approval of PRX-102

The U.S. Food and Drug Administration (FDA) has extended the review date by three months — to spring 2021 — for a biologics license application (BLA) seeking accelerated approval of PRX-102 (pegunigalsidase alfa) to treat adults with Fabry disease. Protalix BioTherapeutics and Chiesi Global Rare Diseases, who are…

AVR-RD-01 Gene Therapy Granted Orphan Drug Status in EU

The European Commission has granted orphan drug designation to Avrobio’s investigational gene therapy AVR-RD-01 for the treatment of Fabry disease. The decision, based on a positive opinion from the Committee for Orphan Medicinal Products of the European Medicines Agency, will provide regulatory and financial incentives for…