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You are here: Industry Insights > Phenylketonuria

News List

FDA grants Orphan Drug Designation to phenylketonuria treatment europeanpharmaceuticalreview
April 08, 2020
A new treatment called APR-OD031 has been given Orphan Drug Designation (ODD) by the FDA, for the treatment of phenylketonuria.
Sapropterin Dihydrochloride Tablets 100 mg drugs
June 17, 2019
Sapropterin Dihydrochloride Tablets 100 mg.
EU approval for Palynziq in adult phenylketonuria pharmatimes
May 09, 2019
The European Commission has approved BioMarin’s Palynziq (pegvaliase injection) for the treatment of phenylketonuria (PKU) in patients aged 16 years or older.
EU approval for Palynziq in adult phenylketonuria pharmatimes
May 09, 2019
The European Commission has approved BioMarin’s Palynziq (pegvaliase injection) for the treatment of phenylketonuria (PKU) in patients aged 16 years or older.
US clears first enzyme therapy for PKU pharmatimes
July 11, 2018
Biomarin’s Palynziq has been approved as the first enzyme therapy to treat the rare brain-threatening genetic disease phenylketonuria (PKU) in adults in the US.
Synlogic Doses First Subject in Phase 1/2a Trial of SYNB1618 for Treatment of Phenylketonuria biospace
April 19, 2018
Synlogi announced that it has dosed the first subject in its Phase 1/2a clinical trial of SYNB1618.