Sichuan Elixir Pharmaceuticals Ursodeoxycholic Acid Sichuan Elixir Pharmaceuticals Ursodeoxycholic Acid

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    • CAPSULE;ORAL - 300MG
    • TABLET;ORAL - 250MG
    • TABLET;ORAL - 500MG
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    Axplora's Ursodeoxycholic Receives 5-Year Renewed Registration
    Axplora's Ursodeoxycholic Receives 5-Year Renewed Registration

    https://www.axplora.com/axploras-ursodeoxycholic-receives-5-year-renewed-registration/

    PRESS RELEASE
    07 Nov 2023
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    Aurobindo's Generic Ursodiol Receives Approval in the U.S.
    Aurobindo's Generic Ursodiol Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214849

    FDA
    28 Nov 2022
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    Bon Secours Liver Institute of Richmond Participating in RESPONSE Study
    Bon Secours Liver Institute of Richmond Participating in RESPONSE Study

    https://www.globenewswire.com/news-release/2022/02/03/2378836/0/en/Bon-Secours-Liver-Institute-of-Richmond-Participating-in-RESPONSE-a-Global-Phase-3-Clinical-Research-Study-Evaluating-an-Investigational-Therapy-for-the-Treatment-of-Primary-Biliar.html

    GLOBENEWSWIRE
    03 Feb 2022
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    Liver Institute NW Participating in RESPONSE, a Global Phase 3 Research Study
    Liver Institute NW Participating in RESPONSE, a Global Phase 3 Research Study

    https://www.globenewswire.com/news-release/2022/02/01/2376714/0/en/Liver-Institute-Northwest-Participating-in-RESPONSE-a-Global-Phase-3-Clinical-Research-Study-Evaluating-an-Investigational-Therapy-for-the-Treatment-of-Primary-Biliary-Cholangitis-.html

    GLOBENEWSWIRE
    01 Feb 2022
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    Commerce ministry begins anti-dumping probe against ursodeoxycholic acid
    Commerce ministry begins anti-dumping probe against ursodeoxycholic acid

    http://www.pharmabiz.com/NewsDetails.aspx?aid=145460&sid=1

    PHARMABIZ
    28 Jan 2022
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    Pinnacle Clinical Research, PLLC Participating in RESPONSE, a Global Phase 3
    Pinnacle Clinical Research, PLLC Participating in RESPONSE, a Global Phase 3

    https://www.globenewswire.com/news-release/2021/11/02/2325679/0/en/Pinnacle-Clinical-Research-PLLC-Participating-in-RESPONSE-a-Global-Phase-3-Clinical-Research-Study-Evaluating-an-Investigational-Therapy-for-the-Treatment-of-Primary-Biliary-Cholan.html

    GLOBENEWSWIRE
    02 Nov 2021
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    The Texas Liver Institute Participating in RESPONSE, a Global Phase 3 Clinical
    The Texas Liver Institute Participating in RESPONSE, a Global Phase 3 Clinical

    https://www.globenewswire.com/news-release/2021/11/02/2325305/0/en/The-Texas-Liver-Institute-Participating-in-RESPONSE-a-Global-Phase-3-Clinical-Research-Study-Evaluating-an-Investigational-Therapy-for-the-Treatment-of-Primary-Biliary-Cholangitis-.html

    GLOBENEWSWIRE
    02 Nov 2021
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    HighTide’s HTD1801 Demonstrates improved effects in Diabetic NASH Patients
    HighTide’s HTD1801 Demonstrates improved effects in Diabetic NASH Patients

    https://www.businesswire.com/news/home/20210921005115/en

    BUSINESSWIRE
    21 Sep 2021
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    Vgyaan's Generic Ursodiol Receives Approval In US
    Vgyaan's Generic Ursodiol Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214329

    FDA
    28 Jul 2021
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    Strides gets USFDA nod for Ursodiol tablets, a liver disease treatment drug
    Strides gets USFDA nod for Ursodiol tablets, a liver disease treatment drug

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/strides-pharma-gets-usfda-nod-for-ursodiol-tablets-a-liver-disease-treatment-drug/articleshow/77670019.cms

    ECONOMICTIMES
    21 Aug 2020
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    Strides Pharma's Generic Ursodiol Receives Approval In US
    Strides Pharma's Generic Ursodiol Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213504

    FDA
    20 Aug 2020
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    Upsher Smith`s Generic Ursodiol Approved in US
    Upsher Smith`s Generic Ursodiol Approved in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213555

    FDA
    20 Aug 2020
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    Nexgen Pharma`s Generic Ursodiol Receives Approval in US
    Nexgen Pharma`s Generic Ursodiol Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205789

    FDA
    13 May 2020
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    CPQ ingenieros conducts the new lebsa plant remodeling
    CPQ ingenieros conducts the new lebsa plant remodeling

    https://www.cpqingenieros.com/cpq-ingenieros-conducts-the-new-lebsa-plant-remodeling/?lang=en

    CPQ
    04 Mar 2020
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    Rising Pharms Generic Ursodiol Receives Approval In US
    Rising Pharms Generic Ursodiol Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213200

    FDA
    15 Feb 2020
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    Eywa Pharma's Generic Ursodiol Receives Approval in US
    Eywa Pharma's Generic Ursodiol Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212452

    FDA
    31 Oct 2019
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    Morepen Labs introduces three new API drugs
    Morepen Labs introduces three new API drugs

    http://www.pharmabiz.com/NewsDetails.aspx?aid=118743&sid=2

    PHARMABIZ
    15 Oct 2019
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    Genfit bags FDA breakthrough tag en route to phase 3 in PBC
    Genfit bags FDA breakthrough tag en route to phase 3 in PBC

    https://www.fiercebiotech.com/biotech/genfit-bags-fda-breakthrough-tag-route-to-phase-3-pbc

    Nick Paul Taylor FIERCE BIOTECH
    18 Apr 2019
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    CymaBay Therapeutics' Seladelpar FDA Breakthrough Therapy Designated
    CymaBay Therapeutics' Seladelpar FDA Breakthrough Therapy Designated

    https://globenewswire.com/news-release/2019/02/15/1726160/0/en/CymaBay-Therapeutics-Announces-Seladelpar-Granted-Breakthrough-Therapy-Designation-by-the-FDA-for-the-Treatment-of-Primary-Biliary-Cholangitis.html

    GLOBENEWSWIRE
    15 Feb 2019
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    Zydus 's Generic Ursodiol Receives Approval in US
    Zydus 's Generic Ursodiol Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211145

    FDA
    31 Oct 2018
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    Amneal Pharms's Generic Ursodiol Receives Approval in US
    Amneal Pharms's Generic Ursodiol Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211301

    FDA
    19 Oct 2018
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    Abhai’s Generic Ursodiol Receives Approval In US
    Abhai’s Generic Ursodiol Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210707

    FDA
    22 May 2018
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    US FDA says excessive Ocaliva poses risk to people with decreased liver function
    US FDA says excessive Ocaliva poses risk to people with decreased liver function

    http://www.in-pharmatechnologist.com/Regulatory-Safety/US-FDA-says-excessive-Ocaliva-poses-risk-to-people-with-decreased-liver-function

    Flora Southey IN PHARMATECHNOLOGIST
    27 Sep 2017
    Share Share
    European Commission Grants Intercept’s Ocaliva Marketing Authorization
    European Commission Grants Intercept’s Ocaliva Marketing Authorization

    https://globenewswire.com/news-release/2016/12/14/897530/0/en/European-Commission-Grants-Intercept-s-Ocaliva-obeticholic-acid-Marketing-Authorization-for-the-Treatment-of-Primary-Biliary-Cholangitis.html

    GLOBENEWSWIRE
    15 Dec 2016
    Share Share
    3 Potential Acquisition Targets for Gilead Sciences, Inc.
    3 Potential Acquisition Targets for Gilead Sciences, Inc.

    http://www.fool.com/investing/2016/11/16/3-potential-acquisition-targets-for-gilead-science.aspx?

    Keith Speights THE MOTLEY FOOL
    16 Nov 2016
    Share Share
    Eight Medicines win CHMP Nod
    Eight Medicines win CHMP Nod

    http://www.pharmatimes.com/news/eight_medicines_win_chmp_nod_1167254

    Selina McKee PHARMATIMES
    18 Oct 2016
    Share Share
    Intercept’s Ocaliva Gains PBC Thumbs in Europe, but with Caveats
    Intercept’s Ocaliva Gains PBC Thumbs in Europe, but with Caveats

    http://www.fiercebiotech.com/biotech/intercept-s-ocaliva-gains-pbc-thumbs-europe-but-caveats

    Ben Adams FIERCE BIOTECH
    15 Oct 2016
    Share Share
    Apotheca Supply, Inc receives warning letter due to cGMP deviations
    Apotheca Supply, Inc receives warning letter due to cGMP deviations

    https://www.pharmacompass.com/pdf/news/apotheca-supply-inc-receives-warning-letter-due-to-cgmp-deviations-1484160849.pdf

    FDA
    07 Apr 2016
    Share Share
    FDA staff raises no major concerns over Intercept's liver drug
    FDA staff raises no major concerns over Intercept's liver drug

    http://www.reuters.com/article/us-intercept-fda-idUSKCN0X21LB

    Amrutha Penumudi REUTERS
    06 Apr 2016
    Share Share
    FDA postpones decision on Intercept's lead liver drug
    FDA postpones decision on Intercept's lead liver drug

    http://www.reuters.com/article/us-intercept-fda-idUSKBN0U032D20151217

    Amrutha Penumudi REUTERS
    18 Dec 2015
    Share Share
    Autoimmune liver disease - Are there spectra that we do not know?
    Autoimmune liver disease - Are there spectra that we do not know?

    http://7thspace.com/headlines/521688/autoimmune_liver_disease___are_there_spectra_that_we_do_not_know.html

    7th SPACE
    11 Dec 2015
    Share Share
    PBC Drug Lowers ALP
    PBC Drug Lowers ALP

    http://www.medpagetoday.com/clinical-context/PBCNASH/54740

    Kristina Fiore MEDPAGE TODAY
    17 Nov 2015
    Share Share
    Obeticholic Acid Durable in Primary Biliary Cirrhosis
    Obeticholic Acid Durable in Primary Biliary Cirrhosis

    http://www.medpagetoday.com/clinical-context/PBCNASH/54719

    Michael Smith MEDPAGE TODAY
    16 Nov 2015
    Share Share
    High-Dose Ursodeoxycholic Acid Fails Test in Primary Sclerosing Cholangitis
    High-Dose Ursodeoxycholic Acid Fails Test in Primary Sclerosing Cholangitis

    http://www.medpagetoday.com/MeetingCoverage/AASLD/11632

    Charles Bankhead MEDPAGE TODAY
    05 Nov 2015
    Share Share
    Cerilliant Introduces Certified Spiking Solutions of Bile Acids
    Cerilliant Introduces Certified Spiking Solutions of Bile Acids

    http://www.prnewswire.com/news-releases/cerilliant-introduces-certified-spiking-solutions-of-bile-acids-300156271.html

    PR NEWSWIRE
    08 Oct 2015
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    Canadian advance in solving brain disease
    Canadian advance in solving brain disease

    http://www.rcinet.ca/en/2015/09/14/prion-alzheimers-parkinsons-canadian-advance-in-solving-brain-disease/

    Marc Montgomery RCI
    14 Sep 2015
    Share Share
    Finding a way forward in the fight against prion disease
    Finding a way forward in the fight against prion disease

    http://www.eurekalert.org/pub_releases/2015-09/uoaf-faw090315.php

    EUREKALERT
    03 Sep 2015
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    FDA Grants Priority Review for Intercept's Obeticholic Acid
    FDA Grants Priority Review for Intercept's Obeticholic Acid

    http://globenewswire.com/news-release/2015/08/31/764658/10147585/en/FDA-Grants-Priority-Review-for-Intercept-s-Obeticholic-Acid-for-the-Treatment-of-Primary-Biliary-Cirrhosis.html

    GLOBE NEWSWIRE
    31 Aug 2015
    Share Share
    Laparoscopic Cholecystectomy Prevent Recurrent Idiopathic Acute Pancreatitis?
    Laparoscopic Cholecystectomy Prevent Recurrent Idiopathic Acute Pancreatitis?

    http://www.medscape.com/viewarticle/854010

    Sari Räty MEDSCAPE
    31 Aug 2015
    Share Share
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