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  • TABLET;ORAL - 500MG
  • POWDER;ORAL - 3GM/TEASPOONFUL

https://www.fiercebiotech.com/biotech/nearly-week-after-pulling-relyvrio-amylyx-engage-regulators-about-path-another-rare-disease

Gabrielle Masson FIERCE BIOTECH
11 Apr 2024

https://www.amylyx.com/news/amylyx-pharmaceuticals-announces-formal-intention-to-remove-relyvrior/albriozatm-from-the-market-provides-updates-on-access-to-therapy-pipeline-corporate-restructuring-and-strategy

PRESS RELEASE
05 Apr 2024

https://www.businesswire.com/news/home/20240404501040/en

BUSINESSWIRE
04 Apr 2024

https://www.globenewswire.com/news-release/2024/03/28/2854508/16626/en/Zevra-Therapeutics-Reports-Fourth-Quarter-and-Full-Year-2023-Financial-Results-and-Corporate-Updates.html

GLOBENEWSWIRE
28 Mar 2024

https://www.amylyx.com/news/amylyx-pharmaceuticals-announces-topline-results-from-global-phase-3-phoenix-trial-of-amx0035-in-als

PRESS RELEASE
09 Mar 2024

https://www.prnewswire.com/news-releases/pheburane-sodium-phenylbutyrate-is-now-on-the-medicaid-preferred-drug-list-in-10-states-302041199.html

PR NEWSWIRE
23 Jan 2024

https://www.businesswire.com/news/home/20231122682452/en

BUSINESSWIRE
27 Nov 2023

https://www.globenewswire.com//news-release/2023/10/26/2767387/0/en/Pheburane-sodium-phenylbutyrate-coverage-to-reach-80-of-commercially-insured-US-patients-by-January-1st-2024.html

GLOBENEWSWIRE
26 Oct 2023

https://www.fiercepharma.com/pharma/amylyxs-als-drug-relyvrio-rebuffed-eus-chmp-again

Zoey Becker FIERCE PHARMA
14 Oct 2023

https://www.businesswire.com/news/home/20231002273497/en

BUSINESSWIRE
02 Oct 2023

https://www.globenewswire.com/news-release/2023/08/09/2721462/0/en/Pheburane-sodium-phenylbutyrate-coverage-rapidly-expands-to-the-benefit-of-Americans-with-certain-urea-cycle-disorders-UCDs.html

GLOBENEWSWIRE
09 Aug 2023

https://endpts.com/european-regulatory-committee-recommends-rejecting-amylyx-als-drug/

Max Gelman ENDPTS
24 Jun 2023

https://endpts.com/amylyx-says-relyvrio-earns-71m-in-revenue-plans-to-test-drug-in-rare-brain-disorder/

Tyler Patchen ENDPTS
12 May 2023

https://www.pharmiweb.com/press-release/2023-05-01/relief-therapeutics-announces-collaboration-partner-reports-olpruva-commercial-launch-progressing-a

PHARMIWEB
01 May 2023

https://www.accesswire.com/viewarticle.aspx?id=743831&lang=en

ACCESSWIRE
15 Mar 2023

https://www.fiercepharma.com/special-reports/2022-drug-approvals-after-aduhelm-fiasco-fda-endorsements-were-harder-come

Kevin Dunleavy FIERCE PHARMA
03 Jan 2023

https://pipelinereview.com/index.php/2022122382377/Antibodies/UCB-Announces-FDA-Acceptance-of-BLA-Resubmission-for-Bimekizumab.html

PIPELINEREVIEW
23 Dec 2022

https://www.expresspharma.in/us-fda-gives-final-approval-to-glenmark-pharmas-sodium-phenylbutyrate-tablets/

EXPRESSPHARMA
03 Nov 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216462

FDA
01 Nov 2022

https://www.fiercepharma.com/pharma/amylyxs-als-drug-finally-scores-fda-approval-thats-just-tip-iceberg-als-research-amylyx-co

Zoey Becker FIERCEPHARMA
30 Sep 2022

https://investors.amylyx.com/news-releases/news-release-details/amylyx-pharmaceuticals-announces-donated-centaur-clinical-trial

PRESS RELEASE
14 Sep 2022

https://www.businesswire.com/news/home/20220914005209/en

BUSINESSWIRE
14 Sep 2022

https://www.businesswire.com/news/home/20220912005236/en

BUSINESSWIRE
12 Sep 2022

https://www.businesswire.com/news/home/20220907005824/en/Amylyx-Pharmaceuticals-Stock-Trading-Halted-Today

BUSINESSWIRE
07 Sep 2022

https://www.businesswire.com/news/home/20220907006313/en

BUSINESSWIRE
07 Sep 2022

https://www.businesswire.com/news/home/20220831005780/en

BUSINESSWIRE
02 Sep 2022

https://www.businesswire.com/news/home/20220811005026/en

BUSINESSWIRE
11 Aug 2022

https://www.businesswire.com/news/home/20220802006047/en

BUSINESSWIRE
03 Aug 2022

https://www.nasdaq.com/articles/acer-therapeutics-resubmits-nda-for-acer-001-for-treatment-of-urea-cycle-disorders

NASDAQ
19 Jul 2022

https://www.biospace.com/article/releases/relief-therapeutics-announces-that-its-collaboration-partner-has-resubmitted-the-acer-001-sodium-phenylbutyrate-new-drug-application-nda-to-the-fda-for-the-treatment-of-urea-cycle-disorders-ucds-/

BIOSPACE
18 Jul 2022

https://www.amylyx.com/media/amylyx-pharmaceuticals-announces-health-canada-approval-of-albriozatm-for-the-treatment-of-als

AMYLYX
13 Jun 2022

https://www.businesswire.com/news/home/20220330005162/en

BUSINESSWIRE
30 Mar 2022

https://www.businesswire.com/news/home/20220328005619/en

BUSINESSWIRE
28 Mar 2022

https://www.businesswire.com/news/home/20220224005861/en

BUSINESSWIRE
25 Feb 2022

https://www.businesswire.com/news/home/20220203005226/en

BUSINESSWIRE
03 Feb 2022

https://www.biospace.com/article/releases/relief-announces-that-collaboration-partner-acer-therapeutics-was-issued-u-s-patent-11-202-767-covering-acer-001-methods-of-use-for-treatment-of-urea-cycle-disorders-and-maple-syrup-urine-disease/

BIOSPACE
01 Feb 2022

https://www.businesswire.com/news/home/20220104005424/en

BUSINESSWIRE
04 Jan 2022

https://www.globenewswire.com/news-release/2021/10/26/2320658/0/en/Acer-Therapeutics-and-Relief-Therapeutics-Announce-Issuance-of-U-S-Patent-11-154-521-Covering-ACER-001-Formulation.html

GLOBENEWSWIRE
26 Oct 2021

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-october-6-2021-1633509984.pdf

FDA
06 Oct 2021

https://www.globenewswire.com/news-release/2021/10/06/2309550/0/en/Acer-Therapeutics-and-Relief-Therapeutics-Announce-FDA-Acceptance-for-Filing-of-New-Drug-Application-for-ACER-001-to-Treat-Urea-Cycle-Disorders.html

GLOBENEWSWIRE
06 Oct 2021

https://www.businesswire.com/news/home/20210915005297/en

BUSINESSWIRE
15 Sep 2021

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-september-1-2021-1630499458.pdf

FDA
01 Sep 2021

https://www.businesswire.com/news/home/20191004005428/en

BUSINESSWIRE
04 Oct 2019

https://www.biospace.com/article/following-crl-acer-therapeutics-restructures-company-lays-off-29/

Alex Keown BIOSPACE
08 Jul 2019

https://www.fiercebiotech.com/biotech/fda-kicks-back-acer-s-rare-disease-drug-demands-new-test-shares-freefall

Ben Adams FIERCE BIOTECH
26 Jun 2019

https://www.fiercebiotech.com/orion-take-repurposed-heart-failure-drug-into-phase-3-for-als

Phil Taylor FIERCE BIOTECH
06 Jul 2018

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-may-24-2017-1495779323.pdf

FDA
24 May 2017

http://www.prnewswire.com/news-releases/sobi-and-horizon-pharma-enter-five-year-distribution-agreement-for-ravicti-and-ammonaps-outside-the-united-states-300374421.html

PR NEWSWIRE
07 Dec 2016

http://www.in-pharmatechnologist.com/Regulatory-Safety/Pii-faces-EU-ban-following-GMP-issues-at-Maryland-facilities

Dan Stanton IN-PHARMATECHNOLOGIST
19 Sep 2016

http://raps.org/Regulatory-Focus/News/2016/09/16/25864/EMA-Recommends-Ban-of-US-CMO%E2%80%99s-Medicines/

Zachary Brennan RAPS
16 Sep 2016
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