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    US FDA Approves First Treatment for Rare Disease in Males
    US FDA Approves First Treatment for Rare Disease in Males

    20 Sep 2025

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-first-treatment-rare-life-threatening-disease-males-2025-09-19/

    REUTERS
    20 Sep 2025
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    Stealth Biotherapeutics`s Forzinity Receives Approval in US
    Stealth Biotherapeutics`s Forzinity Receives Approval in US

    19 Sep 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215244

    FDA
    19 Sep 2025
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    Stealth, Barth Community Await FDA Verdict With All at Stake
    Stealth, Barth Community Await FDA Verdict With All at Stake

    16 Sep 2025

    // BIOSPACE

    https://www.biospace.com/drug-development/stealth-barth-community-await-fda-verdict-with-everything-at-stake

    BIOSPACE
    16 Sep 2025
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    Stealth to Cut Jobs After FDA Rejects Therapy for Rare Disorder
    Stealth to Cut Jobs After FDA Rejects Therapy for Rare Disorder

    29 May 2025

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-asks-stealth-biotherapeutics-resubmit-application-rare-genetic-condition-2025-05-29/

    REUTERS
    29 May 2025
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    Barth Syndrome Foundation Urges FDA Action on Elamipretide Delay
    Barth Syndrome Foundation Urges FDA Action on Elamipretide Delay

    29 Apr 2025

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20250429986004/en/Barth-Syndrome-Foundation-Calls-for-Urgent-FDA-Action-Following-Elamipretide-Delay

    BUSINESSWIRE
    29 Apr 2025
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    FDA Advisory Committee To Review Stealth's Elamipretide For Barth Syndrome
    FDA Advisory Committee To Review Stealth's Elamipretide For Barth Syndrome

    09 Sep 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/stealth-biotherapeutics-announces-fda-advisory-committee-meeting-to-review-elamipretide-for-barth-syndrome-treatment-302242393.html

    PR NEWSWIRE
    09 Sep 2024
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