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    Eton Announces Commercial Availability of Nitisinone Capsules
    Eton Announces Commercial Availability of Nitisinone Capsules

    https://www.globenewswire.com//news-release/2024/02/02/2822744/0/en/Eton-Pharmaceuticals-Announces-Commercial-Availability-of-Ultra-Rare-Disease-Product-Nitisinone-Capsules.html

    GLOBENEWSWIRE
    02 Feb 2024
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    Torrent's Generic Nitisinone Receives Approval in the U.S.
    Torrent's Generic Nitisinone Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215908

    FDA
    09 Jan 2023
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    Sobi’s Orfadin Receives Positive Opinion From CHMP For Treatment Of AKU
    Sobi’s Orfadin Receives Positive Opinion From CHMP For Treatment Of AKU

    http://www.pharmabiz.com/NewsDetails.aspx?aid=131249&sid=2

    PHARMABIZ
    20 Sep 2020
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    Orfadin® (nitisinone) receives positive opinion from CHMP for treatment of AKU
    Orfadin® (nitisinone) receives positive opinion from CHMP for treatment of AKU

    https://www.biospace.com/article/releases/orfadin-nitisinone-receives-positive-opinion-from-chmp-for-treatment-of-aku/

    BIOSPACE
    18 Sep 2020
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    Meeting highlights from Committee for Medicinal Products for Human Use (CHMP)
    Meeting highlights from Committee for Medicinal Products for Human Use (CHMP)

    https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-september-2020

    EMA
    18 Sep 2020
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    FDA Approvals Roundup: Detectnet, Nityr, Trelegy Ellipta
    FDA Approvals Roundup: Detectnet, Nityr, Trelegy Ellipta

    https://www.raps.org/news-and-articles/news-articles/2020/9/fda-approvals-roundup-detectnet-trelegy-ellipta-ni

    R. Matthews RAPS
    16 Sep 2020
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    US FDA Grants Once Daily Dosing Option for NITYR Tablets for HT-1 Patients
    US FDA Grants Once Daily Dosing Option for NITYR Tablets for HT-1 Patients

    https://www.businesswire.com/news/home/20200914005235/en/US-FDA-Grants-Once-Daily-Dosing-Option-for-NITYR-nitisinone-Tablets-for-HT-1-Patients

    BUSINESSWIRE
    14 Sep 2020
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    Cycle Pharmaceuticals Secures $25 Million Debt Financing
    Cycle Pharmaceuticals Secures $25 Million Debt Financing

    https://www.businesswire.com/news/home/20200906005026/en

    BUSINESSWIRE
    06 Sep 2020
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    Novitium Pharma`s Generic Nitisinone Receives Approval in US
    Novitium Pharma`s Generic Nitisinone Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211041

    FDA
    27 Aug 2019
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    Celgene Europe BV Generic Azacitidine Receives Approval in Europe
    Celgene Europe BV Generic Azacitidine Receives Approval in Europe

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

    EMA
    08 Aug 2019
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    Copycats wanted: Pfizer, AZ and more under threat as China solicits generics
    Copycats wanted: Pfizer, AZ and more under threat as China solicits generics

    https://www.fiercepharma.com/pharma-asia/foreign-drugmakers-under-threat-as-china-rolls-out-drug-list-to-boost-generic

    Angus Liu FIERCE PHARMA
    21 Jun 2019
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    Cycle Pharmaceuticals' Nityr (nitisinone) Receives Approval in Europe
    Cycle Pharmaceuticals' Nityr (nitisinone) Receives Approval in Europe

    http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/004582/WC500253741.pdf

    EMA
    10 Aug 2018
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    MendeliKABS Europe's Nitisinone MDK Receives Approval In Europe
    MendeliKABS Europe's Nitisinone MDK Receives Approval In Europe

    https://www.pharmacompass.com/pdf/news/mendelikabs-europes-nitisinone-mdk-receives-approval-in-europe-1507274291.pdf

    EMA
    06 Oct 2017
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    Swedish Orphan Biovitrum AB - Orfadin Capsules Approved in the Kingdom of Saudi Arabia
    Swedish Orphan Biovitrum AB - Orfadin Capsules Approved in the Kingdom of Saudi Arabia

    http://www.prnewswire.com/news-releases/swedish-orphan-biovitrum-ab---orfadin-capsules-approved-in-the-kingdom-of-saudi-arabia-for-the-treatment-of-hereditary-tyrosinemia-type-1-300459100.html

    PR NEWSWIRE
    16 May 2017
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    Dipharma announces the validation of disanit® (nitisinone) marketing authorization application in Europe
    Dipharma announces the validation of disanit® (nitisinone) marketing authorization application in Europe

    https://www.pharmacompass.com/pdf/news/Dipharma-announces-the-validation-of-disanit-nitisinone-marketing-authorization-application-in-Europe-1487846057.pdf

    PRESS RELEASE
    23 Feb 2017
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    WEP Clinical & MendeliKABS enter exclusive Named Patient distribution agreement
    WEP Clinical & MendeliKABS enter exclusive Named Patient distribution agreement

    http://www.satprnews.com/2017/02/20/wep-clinical-and-mendelikabs-inc-enter-exclusive-named-patient-distribution-agreement-for-mdk-nitisinone/

    SATPRNEWS
    20 Feb 2017
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    Sobi receives European approval for new dosing frequency for Orfadin
    Sobi receives European approval for new dosing frequency for Orfadin

    http://www.pharmabiz.com/NewsDetails.aspx?aid=100202&sid=2

    PHARMABIZ
    06 Feb 2017
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    Sobi Obtains Approval From the European Commission for new Dosing Frequency
    Sobi Obtains Approval From the European Commission for new Dosing Frequency

    http://finance.yahoo.com/news/sobi-obtains-approval-european-commission-074400432.html

    FINANCE YAHOO
    02 Feb 2017
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    Sobi Receives Health Canada Approval for Orfadin Capsules
    Sobi Receives Health Canada Approval for Orfadin Capsules

    http://www.pharmabiz.com/NewsDetails.aspx?aid=99659&sid=2

    PHARMABIZ
    07 Jan 2017
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    Health Canada greenlights MendeliKABS for the commercialization
    Health Canada greenlights MendeliKABS for the commercialization

    http://www.newswire.ca/news-releases/health-canada-greenlights-mendelikabs-for-the-commercialization-of-prmdk-nitisinone-596642781.html

    NEWSWIRE
    11 Oct 2016
    Share Share
    Drug that cures rare disease hereditary tyrosinaemia type 1 gets approval
    Drug that cures rare disease hereditary tyrosinaemia type 1 gets approval

    http://www.news.com.au/lifestyle/health/health-problems/drug-that-cures-rare-disease-hereditary-tyrosinaemia-type-1-gets-approval-on-life-saving-drugs-program/news-story/b929b5a0ef36a637f4b44045963e4739

    Rebecca Sullivan NEWS
    09 Jul 2016
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    FDA approves Sobi's Orfadin 20 mg caps. to treat hereditary tyrosinaemia type-1
    FDA approves Sobi's Orfadin 20 mg caps. to treat hereditary tyrosinaemia type-1

    http://www.pharmabiz.com/NewsDetails.aspx?aid=95784&sid=2

    PHARMABIZ
    17 Jun 2016
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    FDA approves higher dosage strength Orfadin capsule for HT-1 treatment
    FDA approves higher dosage strength Orfadin capsule for HT-1 treatment

    http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda-approves-higher-dosage-strength-orfadin-capsule-for-ht-1-treatment-160616-4924529

    PBR
    15 Jun 2016
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    Canada confirms its first sexually transmitted Zika case
    Canada confirms its first sexually transmitted Zika case

    http://www.reuters.com/article/us-health-zika-canada-idUSKCN0XM29Q

    Rod Nickel REUTERS
    25 Apr 2016
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    Sobi's Orfadin oral suspension gets EU patent to treat hereditary tyrosinaemia
    Sobi's Orfadin oral suspension gets EU patent to treat hereditary tyrosinaemia

    http://www.pharmabiz.com/NewsDetails.aspx?aid=92962&sid=2

    PHARMABIZ
    20 Jan 2016
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    Orphan drug firm Sobi opens new European base
    Orphan drug firm Sobi opens new European base

    http://www.pmlive.com/pharma_news/orphan_drug_firm_sobi_opens_new_european_base_818570

    Dominic Tyer PM LIVE
    11 Sep 2015
    Share Share
    Sobi's Orfadin® (Nitisinone Oral Suspension) Approved in EU For Type-1 Tyrosinaemia
    Sobi's Orfadin® (Nitisinone Oral Suspension) Approved in EU For Type-1 Tyrosinaemia

    http://www.sobi.com/en/Investors--Media/News/RSS/?RSS=http://cws.huginonline.com/S/134557/PR/201506/1932326.xml

    SOBI
    30 Jun 2015
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