PBF-999, the first in class treatment in development for the Prader-Willi Syndrome has received “Orphan Drug Designation” by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA)

by Palobiofarma

The Orphan Drug Designation indicates the acknowledgement by the Regulatory Authorities of USA and the EU that PBF-999 have the potential to address the specific needs of individuals suffering from Pr...

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Palobiofarma Receives Rare Pediatric Disease Designation from the U.S. FDA for PBF-999 for the Treatment of Prader-Willi Syndrome

by Palobiofarma

Palobiofarma has announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) Designation for the company’s phosphodiesterase 10 (PDE-10) inhibitor, PBF-999, f...

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