FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease

29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...

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Achieve Life Sciences announces FDA acceptance of cytisinicline new drug application for treatment of nicotine dependence for smoking cessation

3 September 2025 - Achieve Life Sciences today announced that the US FDA has accepted the cytisinicline new drug application for ...

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Australian scientists in hunt for cutting edge treatments, medicine

3 September 2025 - A mission to improve our notoriously slow medicine access system will seek innovations around the globe. ...

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Menarini Group's obicetrapib and obicetrapib/ezetimibe marketing authorisation applications accepted for review by the EMA for the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia

2 September 2025 - Menarini today announced that EMA has validated the marketing authorisation application for obicetrapib, a selective cholesteryl ...

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FDA accepts Shionogi’s ensitrelvir NDA as the first oral therapy for the prevention of COVID-19 following exposure

2 September 2025 - Shionogi announced the US FDA has accepted a new drug application for ensitrelvir fumaric acid, an investigational ...

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Rolling sBLA initiated to the US FDA for Leqembi Iqlik (lecanemab-irmb) as a subcutaneous starting dose for the treatment of early Alzheimer's disease under fast track status

3 September 2025 - BioArctic partner Eisai announced today that they have initiated a rolling submission of the supplemental biologics license ...

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ICER publishes final evidence report on treatments for spinal muscular atrophy

2 September 2025 - Independent appraisal committee votes reflect uncertainty in net health benefit for apitegromab and for add-on treatments ...

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'More than my rent': NSW woman's $1000 a month fight for relief

3 September 2025 - Six years ago, Raphaella Kathryn Crosby could barely get out of bed. ...

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Health Canada approves Elahere for certain types of platinum-resistant ovarian cancers

2 September 2025 - Elahere received approval through Health Canada's priority review process, based on data from the pivotal MIRASOL Phase ...

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DoH publishes revised agenda for September 2025 PBAC meeting (version 2)

2 September 2025 - The agenda for the September 2025 PBAC meeting has now been updated. ...

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Multiple myeloma drug Darzalex to get expanded coverage from September

29 August 2025 - Starting in September, reimbursement for the multiple myeloma treatment Darzalex (daratumumab) will be expanded, reducing the ...

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Cost of PBS scripts to be dropped to $25 from January 1 2026

2 September 2025 - Prescriptions listed on the PBS will be cut from $31.60 to $25 from January 1, 2026, ...

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New free vaccine to protect kids against pneumococcal

2 September 2025 - Australian children will now have stronger protection against pneumococcal with the Australian Government implementing a new ...

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PHARMAC confirms continued access to Comirnaty COVID-19 vaccine

1 September 2025 - PHARMAC has secured a new supply agreement with Pfizer to continue funding the Comirnaty brand of ...

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Care for people with rare and less common cancers ‘delayed and fragmented’, new report reveals

1 September 2025 - A national survey of nearly 2,500 people affected by cancer has found those with a rare ...

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More cheaper medicines now available for Australians

1 September 2025 - From today, Australians with paediatric psoriasis, fibrodysplasia, asthma, cystic fibrosis and blood cancer now have access ...

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