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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Cost of life-saving heart disease drugs slashed, saving patients thousands

27 November 2022 - Life-saving medicines that tackle Australia's biggest killer are about to be added to the Pharmaceutical Benefits ...

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The cruellest tax: clipping the ticket on unfunded cancer drugs

28 November 2022 - Jo McKenzie-McLean’s life was turned upside down after a stage 4 bowel cancer diagnosis. ...

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GSK Canada submits respiratory syncytial virus vaccine candidate for regulatory review

25 November 2022 - Application includes important pivotal Phase 3 data evaluating the efficacy and safety of our vaccine candidate against ...

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Taiho Pharmaceutical obtains additional indication of "post-operative adjuvant chemotherapy for hormone receptor positive and HER2 negative breast cancer at high risk of recurrence" for oral anti-cancer agent TS-1

24 November 2022 - Based on POTENT study results. ...

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Spectrum Pharmaceuticals receives complete response letter from US Food and Drug Administration for poziotinib

25 November 2022 - Spectrum Pharmaceuticals today announced that the Company has received a complete response letter from the US FDA ...

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Hugel's 'Letybo' first in Korea to obtain marketing approval from Australia

 24 November 2022 - Obtained marketing approval on the 23rd (local time) from the TGA of Australia for the indication of ...

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Junshi Biosciences announces submission of a marketing authorisation application for toripalimab to the UK MHRA

24 November 2022 - Second marketing authorisation application submission in Europe reflects toripalimab’s steady yet speedy progress towards global commercialisation. ...

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Health Canada authorises Polivy (polatuzumab vedotin) for the first-line treatment of adults with large B-cell lymphoma

24 November 2022 - Authorization is based on pivotal data from the Phase 3 POLARIX trial, which met its primary ...

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GPs can't prescribe ADHD medication, some say that's a problem

24 November 2022 - When Ben Mitchell was first diagnosed with attention deficit hyperactivity disorder (ADHD), he waited four months to ...

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New life-extending treatment for rare forms of advanced gastro-oesophageal cancer recommended by NICE

24 November 2022 - Around 3,000 people could be eligible for a new life-extending combination therapy to treat rare forms of ...

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Camurus announces that Braeburn resubmits NDA for Brixadi in the US

23 November 2022 - Camurus today announced that its US licensee Braeburn has resubmitted the new drug application for Brixadi (buprenorphine) ...

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Enhertu approved in Japan for patients with previously treated HER2 positive metastatic breast cancer

24 November 2022 - Approval broadens indication for Enhertu to earlier use in metastatic breast cancer and requirement for confirmatory ...

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Outcome in relation to discussion of COVID-19 oral treatments – November 2022 PBAC meeting

24 November 2022 - A PBAC outcome in relation to discussion of COVID-19 oral treatments at the November 2022 meeting has ...

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Luspatercept for the treatment of patients with anaemia caused by myelodysplastic syndrome

24 November 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...

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Luspatercept for the treatment of patients with anaemia caused by beta thalassaemia

24 November 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use of ...

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