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https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761079

FDA
09 Dec 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761079

FDA
25 Nov 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761079

FDA
08 Oct 2020

https://www.prnewswire.com/news-releases/biomarin-pioneer-in-rare-disease-treatments-for-phenylketonuria-pku-receives-fda-approval-of-label-expansion-to-allow-maximum-dose-of-60-mg-for-palynziq-pegvaliase-pqpz-injection-for-treatment-of-adults-with-pku-301147358.html

PRNEWSWIRE
07 Oct 2020

http://www.pmlive.com/pharma_news/eu_nod_for_biomarins_second_pku_therapy_palynziq_1286947

Andrew McConaghie PMLIVE
07 May 2019

http://www.news.sanofi.us/2019-05-07-Dupixent-R-dupilumab-Approved-for-Severe-Asthma-by-European-Commission

PRESS RELEASE
07 May 2019

http://www.pmlive.com/pharma_news/eu_nod_for_biomarins_second_pku_therapy_palynziq_1286947

Andrew McConaghie PMLIVE
07 May 2019

https://www.prnewswire.com/news-releases/european-commission-approves-palynziq-pegvaliase-injection-for-treatment-of-phenylketonuria-pku-in-patients-aged-16-years-or-older-300844276.html

PR NEWSWIRE
06 May 2019

https://www.prnewswire.com/news-releases/biomarin-receives-positive-chmp-opinion-in-europe-for-palynziq-pegvaliase-injection-for-treatment-of-patients-with-phenylketonuria-pku-aged-16-and-older-300804918.html

PR NEWSWIRE
01 Mar 2019

https://www.drugdevelopment-technology.com/projects/palynziq-pegvaliase-pqpz-for-the-treatment-of-adults-with-phenylketonuria/

DRUG DEVELOPMENT TECH
28 Jul 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761079

FDA
29 May 2018

https://www.fiercepharma.com/pharma/biomarin-scores-long-sought-fda-nod-for-rare-disease-drug-but-can-it-hit-blockbuster-status

A. Weintraub FIERCE PHARMA
26 May 2018
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