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NEWS #PharmaBuzz

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https://www.globenewswire.com/news-release/2026/01/30/3229591/0/en/Chiesi-Global-Rare-Diseases-and-Protalix-BioTherapeutics-Receive-Positive-CHMP-Opinion-for-an-Additional-Dosing-Regimen-of-Every-Four-Weeks-for-Elfabrio-pegunigalsidase-alfa-in-the.html

GLOBENEWSWIRE
30 Jan 2026

https://www.globenewswire.com/news-release/2025/12/16/3206235/0/en/Chiesi-Global-Rare-Diseases-Announces-Health-Canada-Approval-of-Elfabrio-pegunigalsidase-alfa-for-Fabry-Disease.html

GLOBENEWSWIRE
16 Dec 2025

https://pdf.hres.ca/dpd_pm/00082715.PDF

HEALTH CANADA
09 Dec 2025

https://www.globenewswire.com/news-release/2025/11/03/3179856/0/en/Chiesi-Global-Rare-Diseases-and-Protalix-BioTherapeutics-Seek-Re-examination-from-the-EMA-for-the-Negative-Opinion-for-Elfabrio-pegunigalsidase-alfa-Alternative-Dosing-Regimen-of-E.html

GLOBENEWSWIRE
03 Nov 2025

https://www.pmlive.com/pharma_news/nice_recommends_chiesis_elfabrio_for_adults_with_fabry_disease_1497865

PM LIVE
05 Sep 2023

https://www.ema.europa.eu/en/documents/overview/elfabrio-epar-medicine-overview_en.pdf

EMA
25 May 2023