Global Newsroom | CSL

Data Published in the New England Journal of Medicine Confirm the Long-term Durability and Safety of HEMGENIX® (etranacogene dezaparvovec-drlb) Over Five Y…

(51 of 54) remained free from the burden of continuous prophylaxis treatment through five years following a single infusion ...
Global Newsroom | CSL

World-class $1bn vaccine and antivenom manufacturing facility opens in Melbourne

Australia’s onshore vaccine manufacturing capabilities took a leap forward today as The Hon Mark Butler MP, Minister for ...
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Global Newsroom

- 94% of patients (51 of 54) remained free from the burden of continuous prophylaxis treatment through five years following a single infusion of HEMGENIX, demonstrating sustained therapeutic... CSL ...
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Japan's Ministry of Health, Labour and Welfare Approves CSL and Arcturus Therapeutics' ARCT-154, the first Self-Amplifying mRNA vaccine approved for COVID in adults

This historic approval of the world's first Self-Amplifying messenger RNA (sa-mRNA) COVID-19 Vaccine underscores CSL's promise to develop and deliver innovations when there is a public health need ...
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U.S. Food and Drug Administration Approves CSL's ANDEMBRY® (garadacimab-gxii), the Only Prophylactic Hereditary Angioedema (HAE) Treatment Targeting Factor XIIa with Once ...

ANDEMBRY inhibits the top of the HAE cascade by targeting factor XIIa and provides sustained protection from attacks Once-monthly dosing reduced HAE attacks by a median of more than 99 percent and a ...
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European Commission Approves CSL's ANDEMBRY® (garadacimab) for the Prevention of Recurrent Attacks of Hereditary Angioedema (HAE)

- ANDEMBRY ®, the first and only once-monthly treatment targeting factor XIIa to prevent attacks in HAE patients, inhibits plasma protein factor XIIa, which initiates the cascade of events leading to ...
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CSL to invest approximately $1.5b in U.S. to manufacture plasma-derived therapies

Builds on company’s more than $3b U.S. investment since 2018 which created thousands of new jobs across 44 states KING OF PRUSSIA, PA, USA – November 18, 2025 — Global biopharma leader CSL (ASX:CSL; ...
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CSL Seqirus secures multi-year pandemic preparedness agreement as part of its continued partnership with the UK government

CSL Seqirus will provide its registered pandemic influenza vaccine to the UK if an influenza pandemic occurs during the next four years. This new agreement to CSL Seqirus follows more than ten years ...
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CSL Announces Top-line Results from the Phase 3 AEGIS-II Trial Evaluating the Efficacy and Safety of CSL112 (apolipoprotein A-I [human])

KING OF PRUSSIA, Pa., Feb. 11, 2024 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced top-line results from the Phase 3 AEGIS-II trial evaluating the efficacy and ...
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U.S. Food and Drug Administration approves CSL's HEMGENIX® (etranacogene dezaparvovec-drlb), the first gene therapy for hemophilia B

- This historic approval provides a new treatment option that reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy and generates elevated and sustained factor IX ...
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CSL's Garadacimab, a First-in-Class Factor XIIa Inhibitor, Receives FDA and EMA Filing Acceptance

These regulatory milestones bring CSL one step closer to delivering on our promise to patients with a first-in-class recombinant monoclonal antibody for people living with HAE, a community CSL has ...