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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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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Idebenone accepted by FDA for priority review for Leber hereditary optic neuropathy

22 September 2025 - Chiesi Global Rare Diseases today announced the US FDA is evaluating the regulatory submission of idebenone to ...

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European Commission approves Servier's Voranigo (vorasidenib) as the first targeted therapy for grade 2 IDH mutant glioma in the EU

22 September 2025 - Voranigo demonstrated significant improvement in progression-free survival with a favourable safety profile in a pivotal Phase ...

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FDA takes action to make a treatment available for autism symptoms

22 September 2025 - The US FDA today initiated the approval of leucovorin calcium tablets for patients with cerebral folate ...

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MavriX Bio receives FDA fast track designation for MVX-220 for treatment of Angelman syndrome

22 September 2025 - MavriX Bio today announced that the US FDA has granted fast track designation for MVX-220, an investigational ...

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Update on the US regulatory review of tolebrutinib in non-relapsing, secondary progressive multiple sclerosis

22 September 2025 - The US FDA has extended by three months the target action date of its review of the ...

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