TGA approves new cancer medicine

7 September 2021 - Luspatercept (Reblozyl) is used to treat patients with certain transfusion-dependent anaemias. ...

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TGA grants provisional determination to Celltrion Healthcare's anti-viral COVID-19 treatment regdanvimab

23 August 2021 - On 20 August 2021 the TGA granted provisional determination to Celltrion Healthcare in relation to regdanvimab. ...

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TGA grants provisional determination to Roche combination COVID-19 treatment casirivimab and imdevimab (Ronapreve)

23 August 2021 - On 20 August 2021 the TGA granted provisional determination to Roche in relation to the combination ...

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TGA approves new COVID-19 treatment for use in Australia

20 August 2021 - Australians with COVID-19 who are at risk of hospitalisation will now have access to an additional antibody ...

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TGA provisionally approves GlaxoSmithKline's COVID-19 treatment sotrovimab (Xevudy)

20 August 2021 - Today, the Therapeutic Goods Administration granted provisional approval to GSK for its COVID-19 treatment - sotrovimab ...

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TGA reduces timeframe for publishing adverse event reports

19 August 2021 - With strong public interest in adverse event reports relating to COVID-19 vaccinations, and improvements in our ...

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New Alzheimer's drug aducanumab is dividing doctors and patients, as the TGA weighs up its risk-benefit profile

12 August 2021 - After a decades-long career as a biology teacher, John Rodgers applies the strict logic of a ...

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TGA grants provisional determination to MSD's anti-viral COVID-19 treatment molnupiravir

10 August 2021 - On 9 August 2021 the Therapeutic Goods Administration granted provisional determination to MSD in relation to ...

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New contraceptive pill: ‘safer’ Slinda pill with no blood clot risk, no periods available in Australia

8 August 2021 - A new generation contraceptive pill with no blood clot risks, that can be used by almost all ...

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Additional COVID-19 treatment for Australia

8 August 2021 - The Australian Government has secured an initial shipment of over 7,700 doses of the novel monoclonal ...

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Lupus drug will be ‘game changer’

5 August 2021 - The first targeted treatment for the debilitating auto-immune condition lupus could soon be available in Australia after ...

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TGA international engagement strategy 2021-2025

26 July 2021 - The TGA's International Engagement Strategy 2021-2025 describes how working with our international regulatory counterparts will benefit Australians ...

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COVID-19 demand leads to Australian shortages of rheumatoid arthritis drug

25 July 2021 - Australia is facing shortages of a rheumatoid arthritis drug that has been used to treat COVID-19 ...

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Streamlining proprietary ingredient categories

20 July 2021 - To help make the medicines application process more efficient, the TGA no longer allocates proprietary ingredient ...

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Prescription medicines: applications under evaluation (July 2021 update)

14 July 2021 - The TGA has updated its list of applications for new medicines/vaccines or new uses for existing medicines/vaccines ...

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