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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Rollout of new medicines across New Zealand begins

1 October 2024 - Today marks the first day a range of new medicines, including cancer medicines, will start to ...

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New Zealand Pharmaceutical Schedule - 1 October 2024

1 October 2024 - The October 2024 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...

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Fresenius Kabi and Formycon receive US FDA approval for biosimilar Otulfi (ustekinumab-aauz)

30 September 2024 - In accordance with the patent settlement between Fresenius Kabi, Formycon and Johnson & Johnson, Fresenius Kabi has ...

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Medicare Advantage and Medicare prescription drug programs to remain stable as CMS implements improvements to the programs in 2025

27 September 2024 - Today, the CMS announced that average premiums, benefits, and plan choices for Medicare Advantage and the Medicare ...

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FDA approves imaging drug for evaluation of myocardial ischaemia and infarction

27 September 2024 - The US FDA has approved Flyrcado (flurpiridaz F 18) in adult patients with known or suspected coronary ...

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Cost barriers to medication access in Australia: an analysis of the Patient Experience Survey in context

30 September 2024 - In November 2023, the Australian Bureau of Statistics released its 2022–23 Patient Experience Survey data. ...

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Cabotegravir for the prevention of HIV-1 infection in adults and adolescents

26 September 2024 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...

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Enterprise Therapeutics granted rare paediatric disease designation in the US for novel cystic fibrosis investigational therapy ETD001

26 September 2024 - ETD001 is a novel, first in class blocker of the epithelial sodium channel aimed at treating people ...

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Dupixent (dupilumab) approved in the US as the first ever biologic medicine for patients with COPD

27 September 2024 - Following recent approvals in the EU and China, the US approval is based on two landmark Phase ...

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FDA approves selpercatinib for RET fusion-positive medullary thyroid cancer

27 September 2024 - Today, the FDA granted traditional approval to selpercatinib (Retevmo, Eli Lilly) for adult and paediatric patients ...

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Vertex announces Health Canada acceptance of new drug submission for vanzacaftor/tezacaftor/deutivacaftor, a next in class triple combination treatment for cystic fibrosis

26 September 2024 - Vertex Pharmaceuticals today announced that Health Canada has accepted for review its new drug submission for ...

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AbbVie submits biologics license application to the FDA for telisotuzumab vedotin in previously treated non-small cell lung cancer

27 September 2024 - Biologics license application submission for accelerated approval is supported by data from the Phase 2 LUMINOSITY trial ...

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Bayer submits supplemental new drug application to US FDA seeking expanded indication for Nubeqa (darolutamide) in metastatic hormone-sensitive prostate cancer

26 September 2024 - Submission is based on positive results from the investigational pivotal Phase 3 ARANOTE trial that showed Nubeqa ...

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MHRA approves first medicine for rare immune disease APDS

27 September 2024 - The MHRA has on 25 September approved leniolisib phosphate (Joenja) to treat a rare immune disease known ...

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Dupixent (dupilumab) approved in China as the first ever biologic medicine for patients with chronic obstructive pulmonary disease

27 September 2024 - Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based ...

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