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 approves name change of COVID-19 Vaccine AstraZeneca to Vaxzevria

19 August 2021 - The Therapeutic Goods Administration has approved AstraZeneca's submission to change the name of its COVID-19 Vaccine ...

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COVID-19 vaccine weekly safety report (19 August 2021)

19 August 2021 - To 15 August 2021, approximately 15.3 million vaccine doses have been given in Australia – 9.9 million ...

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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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Australian Technical Advisory Group on Immunisation weekly COVID-19 meeting - 11 August 2021 update

12 August 2021 - ATAGI met on Wednesday 11 August 2021 to review the latest developments relating to adverse events observed ...

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Reclassification of software based medical devices

12 August 2021 - Recent changes to regulation of software based medical devices came into effect in early 2021, which ...

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COVID-19 vaccine weekly safety report (12 August 2021)

12 August 2021 - To 8 August 2021, approximately 13.7 million vaccine doses have been given in Australia – 9.1 million ...

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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 head John Skerritt says NSW death toll would be much higher without AstraZeneca vaccine

11 August 2021 - The head of the national medical regulator says NSW would be recording “dozens” of covid deaths 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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Jason Falinski slams TGA’s slow Moderna Covid vaccine approval

10 August 2021 - The TGA took eight months to approve the Moderna Covid-19 vaccine in Australia despite its use in ...

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TGA provisionally approves Moderna’s COVID-19 vaccine

9 August 2021 - Today, the Therapeutic Goods Administration, granted provisional approval to Moderna Australia for its COVID-19 vaccine—Spikevax (elasomeran)—making ...

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COVID-19 vaccine: international collaboration

6 August 2021 - The Therapeutic Goods Administration has strong working relationships with a wide range of international agencies and ...

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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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