Recent News Releases

MELBOURNE – 24 October 2024 – Two scientists have each been awarded CSL Centenary Fellowships, valued at $1.25 million over five years. They are developing...

Temporary marketing authorization is based on statistically significant and clinically meaningful results from the phase-III PROTECT trial ST. GALLEN, Switzerland and SAN DIEGO, Oct. 17, 2024...

Head-to-head data, presented at OPTIONS XII for the Control of Influenza Conference, demonstrates advantage of sa-mRNA over conventional mRNA in duration of immune response; Results highlight CSL...

As we approach the OPTIONS XII for the Control of Influenza, a global scientific meeting that focuses on influenza, there is an enormous sense of pride among all of us at CSL Seqirus. For the...

Veltassa® offers effective and well-tolerated long-term potassium control in chronic kidney disease and chronic heart failure patients 1-5 Zeria Pharmaceutical Co., Ltd. to market Veltassa® in Japan

Approval underscores CSL and Arcturus Therapeutics' commitment to delivering disruptive technologies to combat COVID-19 and other respiratory viral diseases to protect public health KOSTAIVE®,...

CSL Seqirus to provide 665,000 pre-pandemic (zoonotic) vaccines to support fifteen EU and EEA Member States. Outbreaks of highly pathogenic avian influenza (HPAI) viruses in birds and poultry have...

Throughout 2023 and 2024, outbreaks of highly pathogenic avian influenza (HPAI) viruses among birds have been reported in several regions including Africa, Asia, Europe, and North America...

Data follow the approval of the world's first self-amplifying (sa-mRNA) COVID-19 vaccine for adults in Japan. These results add to recently published data on ARCT-154 demonstrating superior...

Under the licensing and distribution agreement, CSL Seqirus will be responsible for applying for regulatory approval, reimbursement and commercialisation of neffyTM (adrenaline nasal spray) ARS...

First non-immunosuppressive therapy for the treatment of IgA Nephropathy (IgAN) approved in Europe Conditional marketing authorization is based on statistically significant and clinically...

Australia’s newest biotech incubator Jumar Bioincubator has officially opened its doors and revealed the first 16 innovative early-stage ventures to take up residency in its much-awaited Melbourne-based facility at an event officiated by Lord Mayor, Sally Capp AO.

CSL Vifor is pleased that its partner Akebia Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Vafseo (vadadustat) tablets for the treatment of...

CSL Vifor today announced that Health Canada has authorized Ferinject (ferric carboxymaltose) for the intravenous (IV) treatment of iron deficiency anemia in adult and pediatric patients one year...

March 7, 2024 During the latter part of 2023 and following notification by the World Health Organization that B/Yamagata lineage viruses have not been confirmed as detected in circulation since...

Committee for Medicinal Products for Human Use (CHMP) recommends approval of the conditional marketing authorization (CMA) for sparsentan for the treatment of IgA nephropathy (IgAN) in Europe...

Strong CSL Behring portfolio growth especially Ig FINANCIAL HIGHLIGHTS4 Revenue $8.05 billion, up 11% at CC3 NPAT $1.90 billion1, up 17% NPAT $1.94 billion1 at CC3, up 20% NPATA $2.02 billion1,2 ,...

Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced top-line results from the Phase 3 AEGIS-II trial evaluating the efficacy and safety of CSL112 (apolipoprotein A-I [human])...

The FDA has been notified of the incident, which occurred at a plasma donation center

Study conducted by Meiji Seika Pharma in Japan Short communication follows previously published data in The Lancet Infectious Diseases demonstrating Immunological Non-Inferiority to Wuhan Strain...

Findings show that convenience of treatment and flexibility of administration, such as at-home treatment options, are of high importance to patients KING OF PRUSSIA, Pa., Jan. 16, 2024...

CSL's HEMGENIX® is a one-time, single-dose treatment for male adults with severe/moderately severe hemophilia B BERN, Switzerland, Jan. 15, 2024 /PRNewswire/ -- Global biotechnology leader CSL...

- Hizentra® is the #1 immune globulin prescribed for Primary Immunodeficiency (PI) in the U.S. - Hizentra is the first and only subcutaneous immune globulin (SCIg) treatment approved for Chronic...

- 4- and 5-gram ZEMAIRA® vials may reduce the number of vials necessary for reconstitution, thereby providing convenience and lowering package waste KING OF PRUSSIA, Pa., Jan. 2, 2024...

Study conducted by Meiji Seika Pharma in Japan Data follow approval of the world's first self-amplifying messenger RNA (sa-mRNA) COVID-19 vaccine for adults by Japan Ministry of Health, Labor and...

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...

HEMGENIX® is the first and only gene therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of hemophilia B and to show sustained efficacy and safety at three years...

Exclusive Partner in Japan, Meiji Seika Pharma advances regulatory approval This historic approval of the world's first Self-Amplifying messenger RNA (sa-mRNA) COVID-19 Vaccine underscores CSL's...

Iron Deficiency Day unites a strong global coalition raising awareness on the serious health impact of iron deficiency and iron deficiency anemia1 This year, the spotlight is on the importance of...

HEMGENIX®, the first and only FDA-approved gene therapy for adults with hemophilia B, wins for Best Product for Rare/Orphan Diseases KING OF PRUSSIA, Pa. and LEXINGTON, Mass., Oct. 27, 2023...

Global biotechnology leader CSL (ASX: CSL) today announced that Health Canada has authorized HEMGENIX® (etranacogene dezaparvovec), the first and only gene therapy for the treatment of hemophilia...

Global biotechnology leader CSL (ASX: CSL; USOTC: CSLLY) announced today that it has signed a Renewable-Linked Power Purchase Agreement (PPA) with Australian energy provider, AGL. AGL was awarded...

MELBOURNE – 12 October 2023 – Two Australian scientists have each been awarded CSL Centenary Fellowships, valued at $1.25 million over five years. They are each developing new kinds of...

MELBOURNE, AUSTRALIA – 04 October 2023 – CSL’s Research Acceleration Initiative (RAI) continues to expand its reach with seven medical researchers awarded new RAI partnerships, including up...

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...

CSL Seqirus presents new data at the 9th ESWI meeting on the impact of effective vaccination campaigns to protect healthcare systems across the world.1,2 The French data highlights how vaccines...

SUMMIT, N.J., September 15, 2023 -- CSL Seqirus, a business of CSL (ASX:CSL), today announced new data that will be presented at the European Scientific Working Group on Influenza (ESWI)...

EMA application supported by Phase 3 primary vaccination study demonstrating primary efficacy endpoint was met An additional Phase 3 booster study demonstrating non-inferiority of immune response...

The 2023 European Society of Cardiology (ESC) guidelines for acute and chronic heart failure (HF) include upgraded recommendations for intravenous (IV) iron supplementation, including Ferinject®...

Melbourne, Australia – 21 August 2023 – Australia today ushered in a new era in scientific and medical innovation, with Prime Minister of Australia, Anthony Albanese officially opening CSL’s...

Global biotechnology leader CSL (ASX: CSL) (USOTC: CSLLY) announced today that Jeffrey Ball, an established global leader across multiple disciplines and functions, has been appointed Chief...

CSL Seqirus is the only influenza vaccine manufacturer that offers differentiated vaccine options for individuals six months of age and older. Since the COVID-19 pandemic, there has been a...

HEMGENIX®, the first and only FDA approved gene therapy for hemophilia B, has been proven to elevate and sustain factor IX levels for years, significantly reduce the rate of annual bleeds versus...

Injectafer® (ferric carboxymaltose) is now the first and only intravenous (i.v.) iron replacement therapy in the U.S. indicated for improvement in exercise capacity in adult patients with...

Melbourne, Monday 22 May CSL Seqirus has today announced that construction of its new state-of-the-art manufacturing facility in Australia has reached its highest point, known as ‘topping...

Recommendation will enable eligible patients in England, Wales and Northern Ireland to access the first licensed treatment for moderate-to-severe chronic kidney disease (CKD)-associated pruritus...

The DUPLEX Study did not achieve the primary efficacy eGFR slope endpoint over 108 weeks of treatment Secondary and topline exploratory endpoints trended favorably for sparsentan Treatment with...

Hizentra® is the first and only immune globulin (Ig) available in prefilled syringes, offering those living with Primary Immunodeficiency (PI) or Chronic Inflammatory Demyelinating Polyneuropathy...

The site will support CSL's growing R&D portfolio, accelerating the development of next-generation mRNA technology for vaccines WALTHAM, Mass., March 27, 2023 /PRNewswire/ -- Global biotechnology...

Melbourne, 1 March 2023 CSL Seqirus (Seqirus Pty Ltd) and Amarin Corporation plc (NASDAQ:AMRN) have today announced the signing of an exclusive license and distribution agreement to commercialise...

Significant reduction in number of attacks support the potential of once-monthly garadacimab as a prophylactic therapy for patients with hereditary angioedema KING OF PRUSSIA, Pa., March 1, 2023...

Majority of patients were attack free during the entire six-month treatment period (61.5%) Study results presented for first time at 2023 AAAAI Annual Meeting; global regulatory submissions...

Data follow the historic approval of the first gene therapy for hemophilia B, which reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy and generates...

CSL recognized in Forbes and Statista's Best Large-sized Employer category for the fourth time since 2018. KING OF PRUSSIA, Pa., Feb. 21, 2023 /PRNewswire/ -- Global biotechnology leader CSL has...

HEMGENIX® underscores CSL's promise to deliver life-changing innovations that have the potential to help patients lead full lives MARBURG, Germany, Feb. 20, 2023 /PRNewswire/ -- Global...

First targeted therapy available for the treatment of two main types of ANCA-associated vasculitis (AAV), a rare and systemic disease

Global biotechnology leader CSL (ASX: CSL) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization (CMA) of etranacogene dezaparvovec.

Vifor Pharma AG ("Vifor") announced today that the Commercial Court St. Gallen has cancelled (kraftlos erklärt) all remaining publicly held registered shares of Vifor with a nominal value of CHF 0.01 each (each a "Vifor Share").

Dr Paul McKenzie appointed Chief Executive Officer and Managing Director of CSL from 6 March 2023 MELBOURNE, Australia, Dec. 12, 2022 /PRNewswire/ -- The Board of Directors of CSL Limited...

CSL to access late-stage next-generation mRNA platform technology, enabling development of vaccines for COVID-19, influenza, multi-pathogen pandemic preparedness and other respiratory pathogens...

Long-term data from the pivotal HOPE-B study show a one-time infusion of HEMGENIX generated elevated and sustained mean factor IX levels and reduced the rate of annual bleeding 24-month results...

China has the world’s largest iron deficiency anemia population with estimated prevalence of 15%1 Approval may also benefit the Chinese healthcare system, among others through implementation of...

Iron Deficiency Day unites a strong international coalition raising awareness on the serious health impact of iron deficiency and iron deficiency anemia1 This year, the focus is on importance of...

Global biotechnology leader CSL (ASX: CSL) today announced that the U.S. Food and Drug Administration (FDA) approved HEMGENIX® (etranacogene dezaparvovec-drlb), the first and only one-time gene therapy for appropriate adults with hemophilia B.

CSL, WEHI, and the University of Melbourne today announced the appointment of an independent operator to oversee and manage the new start-up incubator which will support and grow early-stage Australian biotech companies, providing both lab and office spaces.

Pipeline advancements and investment in innovation and disruptive technologies to help fuel sustainable, profitable growth for CSL's three businesses, CSL Behring, CSL Seqirus and CSL Vifor, in...

CSL Limited (ASX:CSL; USOTC:CSLLY) today announces that its subsidiary, CSL Seqirus, has entered into a collaboration and license agreement with Arcturus Therapeutics Holdings Inc ("Arcturus...

Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY), today announced the company has entered into a Strategic Option and License Agreement with Arizona-based Translational Sciences for their enhanced thrombus dissolving drug candidate, TS23.

Vifor Pharma AG (Vifor) announced today that by decision dated October 19, 2022, SIX Exchange Regulation AG (SER) has approved an extension of the various exemptions from certain disclosure and publicity obligations granted by SER to Vifor Pharma AG previously (see Vifor Pharma AG's ad hoc announcement of August 2, 2022).

Global biotechnology leader CSL’s new global corporate headquarters has been awarded a five-star rating from the Green Building Council of Australia.

Global biotherapeutics leader CSL today announced that two Australian scientists have each been awarded a CSL Centenary Fellowship of $1.25 million over five years.

Vifor Pharma AG (Vifor) announced today that Vifor has received approval for the delisting of the totality of Vifor's registered shares.

Data published in Molecular Therapy – Methods and Clinical Development confirm the potential preclinical benefit of the sa-mRNA technology platform, the next generation of mRNA vaccine technology

CSL Extends Reach of Global Research Acceleration Initiative with Freshly Inked Partnerships to Fast-Track Research Programs

CSL Seqirus, a business of CSL Limited (ASX:CSL), today announced new data highlighting the significant burden influenza places on hospitals and healthcare resource use, as well as on more...

CSL Seqirus, a business of CSL Limited (ASX:CSL), today announced new data from four real-world studies showing the impact that cell-based and adjuvanted influenza vaccines can have in reducing...

CSL Behring K.K. (Head Office: Minato-ku, Tokyo; President and Representative Director: Jean-Marc Morange) announces that it has received a manufacturing and marketing approval from the Ministry of Health, Labour and Welfare for “Berinert® S.C. Injection 2000,” a lyophilized human C1-esterase inhibitor concentrate...

CSL applauds the United States District Court’s decision to issue a preliminary injunction preventing the United States Customs and Border Protection (CBP) from continuing to enforce its ban on plasma donations by Mexican nationals who enter the U.S. on a B-1/B-2 visa.

Bernadette Murdoch, an experienced Australian and global corporate affairs and communications leader across multiple industries, will join CSL and lead its global Reputation Management Center of...

The new facility, once fully open later this calendar year, will be CSL's largest R&D site under one roof, with more than 500 team members working in a state-of-the-art facility offering access to...

CSL Seqirus, a part of CSL Limited (ASX:CSL), today announced new data will be presented at the Options for the Control of Influenza (OPTIONS XI) conference taking place September 26-29, 2022 in...

TGA’s designation underscores CSL’s promise to develop and deliver a truly unique portfolio of patient-focused therapies for people with rare and serious medical conditions

A review decision by the European Medicines Agency (EMA) is expected in the second half of 2023 If approved, sparsentan will be a first-in-class treatment to address the significant unmet medical...

U.S. District Court for the District of Delaware rules Teva Pharmaceuticals infringes VFMCRP patent Disputes with all other Abbreviated New Drug Application (ANDA) filers regarding Velphoro® have...

Kapruvia® (difelikefalin) is the first and only therapy approved through consortium filing for the treatment of chronic kidney disease (CKD)-associated pruritus in hemodialysis patients Therapy...

With this recommendation, eligible patients in England, Wales and Northern Ireland will be able to access the first orally administered therapy for GPA/MPA, two main forms of ANCA-associated...

KING OF PRUSSIA, PA CSL is on track to file for regulatory approvals next year and will present full data set at an upcoming scientific congress 17 Aug 2022 Global biotechnology leader CSL...

CSL Limited (ASX: CSL) Today, CSL advances its vision for a more sustainable future by setting new, tangible targets for carbon emissions reductions. As part of the company's broader...

All business units will incorporate CSL name and branding to signify one company MELBOURNE, Australia, Aug. 10, 2022 /PRNewswire/ -- Global biotech leader CSL today announced that all business...

AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR All regulatory clearances received for the acquisition of Vifor Pharma AG Settlement of the offer is scheduled for 9 August 2022 Seasoned biopharma...

AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR Melbourne, Australia, and St. Gallen, Switzerland, 13 July 2022 – CSL Limited (ASX: CSL; USOTC:CSLLY) today announced an update regarding the Vifor...

Seqirus – a global leader in influenza prevention and a business of CSL Limited (ASX:CSL), – has entered into a multi-year influenza research partnership with the University of Liverpool Pandemic Institute. Under the partnership, Seqirus will participate in research projects and knowledge generation around both the threat of seasonal influenza and the development of innovative approaches to pandemic preparedness and response.

CSL continues to provide medicines to patients around the world. 24 Jun 2022 Safeguarding our people, patients and donors remains our top priority. As the COVID-19 pandemic evolves, CSL continues...

Rankin's first in-person U.S. exhibit in three years showcases portraits and personal stories highlighting the remarkable progress made in understanding and treating hemophilia and hopes for the future

Seqirus, a global leader in influenza prevention and a business of CSL Limited (ASX:CSL), today announced the completion of an expansion to the company’s manufacturing facility in Holly Springs, N.C., supporting the formulation and fill-finish of its cell-based influenza vaccines in pre-filled syringes for global communities.

-- If approved, etranacogene dezaparvovec would be the first gene therapy option for people living with hemophilia B -- This milestone underscores CSL Behring's promise to develop and deliver a...

St. Gallen, Switzerland, 12 May 2022 – CSL Limited (ASX: CSL; USOTC:CSLLY) yesterday announced an update regarding the Vifor Pharma AG acquisition. CSL has previously advised that it expected to...

Statement attributable to Greg Boss, Executive Vice President - Legal, and CSL Limited Group General Counsel. 11 May 2022 We are encouraged by the United States Court of Appeals for the District...

AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR First approved therapy in Europe for the treatment of chronic kidney disease (CKD)-associated pruritus in hemodialysis patients First launches in Europe...

The 500 million international units (IUs) will include product specifically manufactured for donation allowing for a longer shelf life and enabling more people around the world to access...