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RSS FeedPosted by Michael Wonder on 27 Sep 2025
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 ...
Posted by Michael Wonder on 26 Sep 2025
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 ...
Posted by Michael Wonder on 26 Sep 2025
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 ...
Posted by Michael Wonder on 26 Sep 2025
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 ...
Posted by Michael Wonder on 26 Sep 2025
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 ...
Posted by Michael Wonder on 25 Sep 2025
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. ...
Posted by Michael Wonder on 25 Sep 2025
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 ...
Posted by Michael Wonder on 25 Sep 2025
‘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 ...
Posted by Michael Wonder on 25 Sep 2025
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, ...
Posted by Michael Wonder on 24 Sep 2025
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 ...
Posted by Michael Wonder on 24 Sep 2025
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 ...
Posted by Michael Wonder on 24 Sep 2025
PHARMAC proposes funding five medicines and more convenient treatment options to ease pressure on health services
24 September 2025 - New Zealanders living with multiple sclerosis, breast cancer, eye conditions, and lung cancer could benefit from ...
Posted by Michael Wonder on 24 Sep 2025
New subcutaneous formulation of Opdivo receives positive INESSS recommendation for multiple tumour types
23 September 2025 - Milestone decision recognises the value of SC formulation of Opdivo to help support delivery flexibility ...
Posted by Michael Wonder on 24 Sep 2025
FDA use of real world evidence in regulatory decision-making
22 September 2025 - The FDA has a long history of using real world data and real-world evidence to monitor and ...
Posted by Michael Wonder on 24 Sep 2025
Push for taxpayers to fund weight loss drugs for 500,000 Australians
23 September 2025 - Danish pharmaceutical giant Novo Nordisk has asked the Federal Government to subsidise its blockbuster weight loss ...