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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Major breast cancer treatment cost slashed under new PBS listing

28 September 2025 - Thousands of women will pay significantly less for treatment after the Federal Government listed a leading ...

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Health Minister Mark Butler says PBS not for negotiation, Donald Trump announced 100 pc tariff on pharmaceutical goods

26 September 2025 - Health Minister Mark Butler says Australia’s PBS will be protected at all costs, despite a pending ...

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Australia’s progress in genomic medicine too slow, says international health chief

27 September 2025 - An international genomics chief says Australia is slipping behind the rest of the world in genomic medicine ...

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Crinetics announces FDA approval of Palsonify (paltusotine) for the treatment of adults with acromegaly

25 September 2025 - Approval based on data from two pivotal Phase 3 trials where Palsonify was well tolerated and resulted ...

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AbbVie submits new drug application to US FDA for tavapadon for the treatment of Parkinson's fisease

26 September 2025 - Submission supported by data from the Phase 3 TEMPO program that demonstrated symptomatic improvement across the Parkinson's ...

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Evkeeza (evinacumab-dgnb) ANGPTL3 antibody approved in the US for children as young as 1 year old with ultra-rare form of high cholesterol

26 September 2025 - Regeneron Pharmaceuticals today announced that the US FDA has approved Evkeeza (evinacumab-dgnb) ANGPTL3 antibody as an adjunct ...

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HIRA calls for insurance overhaul to ensure access to high cost orphan drugs

26 September 2025 - The Government has proposed that a new health insurance reimbursement system must be designed to ensure ...

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Vertex announces key advancements across kidney portfolio

25 September 2025 - Vertex announced today that the FDA has granted breakthrough therapy designation to povetacicept for the treatment of ...

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Lilly's Kisunla (donanemab) receives marketing authorization by European Commission for the treatment of early symptomatic Alzheimer's disease

25 September 2025 - Approved for earliest symptomatic stages of disease, demonstrating significant slowing of cognitive and functional decline. ...

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FDA approves imlunestrant for ER positive, HER2 negative, ESR1 mutated advanced or metastatic breast cancer

25 September 2025 - Today, the FDA approved imlunestrant (Inluriyo, Eli Lilly), an oestrogen receptor antagonist, for adults with oestrogen ...

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‘A brand new era in Alzheimer’s therapy’: drug cleared by regulator

24 September 2025 - Australia’s drug regulator has approved the registration of an ­amyloid-reducing therapy for Alzheimer’s disease after twice ...

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Artios receives US FDA fast track designation for alnodesertib in ATM negative metastatic colorectal cancer

24 September 2025 - Artios Pharma today announced that the US FDA granted fast track designation to its ATR inhibitor, ...

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Leqembi (lecanemab) approved for the treatment of Alzheimer’s disease in Australia

24 September 2025 - Eisai and Biogen announced today that the TGA of Australia has approved the humanised anti-soluble aggregated ...

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Biogen provides regulatory update on high dose regimen of nusinersen

23 September 2023 - Biogen today announced that the US FDA issued a complete response letter for the Company’s supplemental ...

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Enhertu plus pertuzumab granted priority review in the US as first-line treatment for patients with HER2 positive metastatic breast cancer

24 September 2025 - Based on DESTINY-Breast09 Phase 3 trial results, which showed Enhertu plus pertuzumab reduced the risk of ...

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