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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Doptelet (avatrombopag) approved in the EU for treatment of ITP

20 January 2021 - Sobi today announced that the European Commission has approved an extension of the indication for Doptelet ...

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With a new president and a new Congress, it's time for Medicare drug price negotiation

20 January 2021 - Since passage of the Medicare Modernization Act in 2003, which prohibited Medicare from negotiating prescription drug prices, ...

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TGA grants additional provisional determination for a COVID-19 vaccine

20 January 2021 - The TGA, part of the Department of Health, has granted a provisional determination to Biocelect (on ...

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U.S. FDA accepts for priority review application for Opdivo (nivolumab) combined with chemotherapy as first-line treatment in metastatic gastric cancer, gastro-oesophageal junction cancer and oesophageal adenocarcinoma

20 January 2021 - U.S. FDA assigned a target action date of 25 May 2021. ...

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Patient involvement in relative effectiveness assessments in the European Network for Health Technology Assessment

20 January 2021 - Patient involvement in the process of producing health technology assessments has become increasingly important. In the ...

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U.S. Food and Drug Administration accepts for priority review application for Opdivo (nivolumab) as adjuvant therapy for patients with resected oesophageal or gastro-oesophageal junction cancer

20 January 2021 - Application based on Phase 3 CheckMate-577 trial, in which Opdivo doubled median disease-free survival versus placebo in ...

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Scottish Health Technologies Group: enhancing patient engagement

20 January 2021 - The Scottish Health Technologies Group provides evidence support and advice to the National Health Service in Scotland ...

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AMA call for mass upscaling of home-made drug manufacture

20 January 2021 - The Australian Medical Association has warned of a shortage of essential medications because of supply chain ...

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The representation of public values in health technology assessment to inform funding decisions: the case of Australia's national funding bodies

18 January 2021 - Historically, Australia has been at the forefront of the application of HTA for assessing the effectiveness and ...

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U.S. FDA approves vericiguat for patients with symptomatic chronic heart failure

20 January 2021 - Vericiguat (Verquvo) is the first soluble guanylate cyclase stimulator to be approved for the treatment of symptomatic ...

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Scotland backs Roche’s Rozlytrek for ROS1 lung cancer

19 January 2021 - The Scottish Medicines Consortium has given a green light to Roche’s Rozlytrek for a rare form ...

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Ontario doctors urge domestic drug manufacturing over fears of pandemic shortage

19 January 2021 - Chronic drug shortages have worsened during pandemic, Ontario Medical Association says. ...

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Is Novavax the dark horse of Australia's COVID-19 vaccines?

19 January 2021 - Experts say early clinical data on Australia's third COVID-19 vaccine, Novavax, is promising enough to suggest ...

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COVID-19 vaccines and equity: some Kiwis may get more effective jabs than other

20 January 2021 - Questions have been raised about whether New Zealanders will have equitable access to COVID-19 vaccines, as ...

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Enhertu approved in the EU for the treatment of HER2 positive metastatic breast cancer

20 January 2021 - Approval based on the DESTINY-Breast01 Phase 2 trial which showed clinically meaningful and durable responses in patients ...

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