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https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761164

FDA
09 Feb 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761164

FDA
25 Jan 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://www.europeanpharmaceuticalreview.com/news/176622/first-therapy-approved-haemolytic-anaemia-cold-agglutinin-disease/

EUROPEANPHARMACEUTICALREVIEW
21 Nov 2022

https://www.sanofi.com/en/media-room/press-releases/2022/2022-11-17-17-50-00-2558583

PRESS RELEASE
17 Nov 2022

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

EMA
17 Nov 2022

http://www.pharmabiz.com/NewsDetails.aspx?aid=153303&sid=2

PHARMABIZ
19 Sep 2022

https://www.sanofi.com/en/media-room/press-releases/2022/2022-09-16-15-18-01-2517753

PRESS RELEASE
16 Sep 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761164

FDA
04 Feb 2022

https://www.fiercebiotech.com/biotech/sanofi-s-treatment-for-rare-anemia-hits-goal-second-phase-3

N. P. Taylor FIERCE BIOTECH
12 Jun 2021

https://endpts.com/sanofi-grapples-with-rejection-of-potential-first-in-class-orphan-drug-faults-third-party-manufacturing/

Amber Tong ENDPTS
16 Nov 2020

https://www.pharmiweb.com/press-release/2020-11-16/fda-issues-complete-response-letter-for-sutimlimab-an-investigational-treatment-for-hemolysis-in-adults-with-cold-agglutinin-disease

PHARMIWEB
14 Nov 2020

https://www.reuters.com/article/us-sanofi-products/sanofi-gets-priority-u-s-fda-review-for-sutimlimab-product-idUSKBN22Q0JI?feedType=RSS&feedName=healthNews

Sudip Kar-Gupta REUTERS
14 May 2020
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