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    Chiesi, Protalix Seek EMA Re-Exam for Elfabrio 4-Week Dosing
    Chiesi, Protalix Seek EMA Re-Exam for Elfabrio 4-Week Dosing

    03 Nov 2025

    // GLOBENEWSWIRE

    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
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    NICE recommends Chiesi’s Elfabrio for adults with Fabry disease
    NICE recommends Chiesi’s Elfabrio for adults with Fabry disease

    05 Sep 2023

    // PM LIVE

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

    PM LIVE
    05 Sep 2023
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    Chiesi Farmaceutici's Elfabrio (Pegunigalsidase alfa) Receives Approval in the Europe
    Chiesi Farmaceutici's Elfabrio (Pegunigalsidase alfa) Receives Approval in the Europe

    25 May 2023

    // EMA

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

    EMA
    25 May 2023
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    Chiesi's Biologic Elfabrio (Pegunigalsidase alfa) Receives Approval in the U.S.
    Chiesi's Biologic Elfabrio (Pegunigalsidase alfa) Receives Approval in the U.S.

    09 May 2023

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761161

    FDA
    09 May 2023
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    Protalix & Chiesi gain positive opinion for pegunigalsidase alfa
    Protalix & Chiesi gain positive opinion for pegunigalsidase alfa

    06 Mar 2023

    // John Pinching PHARMATIMES

    https://www.pharmatimes.com/news/protalix_and_chiesi_gain_positive_opinion_for_pegunigalsidase_alfa_1488829

    John Pinching PHARMATIMES
    06 Mar 2023
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    CHMP recommends first pegylated enzyme for Fabry disease
    CHMP recommends first pegylated enzyme for Fabry disease

    27 Feb 2023

    // EUROPEAN PHARMACEUTICAL REVIEW

    https://www.europeanpharmaceuticalreview.com/news/179980/chmp-recommends-first-pegylated-enzyme-for-fabry-disease/

    EUROPEAN PHARMACEUTICAL REVIEW
    27 Feb 2023
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