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RSS FeedPosted 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 ...
Posted by Michael Wonder on 24 Sep 2025
Teva and Medincell’s risperidone LAI approved in Canada as Longavo
23 September 2025 - Teva Canada has received regulatory approval for risperidone long-acting injection from Health Canada for the treatment ...
Posted by Michael Wonder on 23 Sep 2025
FDA issues complete response letter for apitegromab as a treatment for patients with spinal muscular atrophy
23 September 2025 - No other approvability issues cited in complete response letter. ...
Posted by Michael Wonder on 23 Sep 2025
GLP-1 drugs Ozempic and Mounjaro close to reimbursement in diabetes care
23 Septemner 2025 - With GLP-1 receptor agonists nearing reimbursement for diabetes treatment, the Government is preparing tighter oversight and ...
Posted by Michael Wonder on 23 Sep 2025
Lexicon Pharmaceuticals announces update on submission of additional data to US FDA supporting the benefit-risk profile of Zynquista in type 1 diabetes
23 September 2025 - Data obtained from ongoing third-party funded, investigator-sponsored trials have been submitted in effort to address the December ...
Posted by Michael Wonder on 23 Sep 2025
EMA recommends marketing authorisation of AVT03, Alvotech’s proposed biosimilar to Prolia and Xgeva
22 September 2025 - Alvotech today announced that the EMA's CHMP has adopted a positive opinion recommending approval for AVT03, Alvotech’s ...