Australia's first COVID treatment approved

10 July 2020 - The Therapeutic Goods Administration has granted provisional approval to remdesivir (Veklury, Gilead Sciences) as the first ...

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US painkiller to be sold in Australian pharmacies to shore up supply

25 June 2020 - Global pharmaceutical giant Johnson & Johnson has been given approval to sell its US painkiller brand ...

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Submissions received: fees and charges proposal 2020-21

23 June 2020 - On 20 January 2020, the Therapeutic Goods Administration (TGA) released on its website a consultation paper, ...

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Anti-COVID drug may be ready in Australia by the end of the year

21 June 2020 - A global breakthrough on a new antiviral drug that scientists believe could block the coronavirus has ...

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Fees and charges: summary from 1 July 2020

18 June 2020 - The TGA is required to recover its costs for all activities that fall within the scope of ...

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New small cell lung cancer drug accepted for TGA evaluation under Project Orbis

3 June 2020 - TGA has granted provisional designation for new drug lurbinectedin based on encouraging Phase 2 results and high ...

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Off-label drugs a risky business

28 May 2020 - Three years ago a 64cm blood clot caused by a drug used to treat acne, Diane ...

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TGA approves Rozlytrek

25 May 2020 - Roche secures TGA approval for another cancer medicine. ...

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ZolpiMist update

12 May 2020 - SUDA submitted a marketing authorisation application to the TGA for ZolpiMist in April 2019.  ...

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Half yearly performance snapshot: July to December 2019

6 May 2020 - The TGA prepares an annual TGA Business Plan, which identifies the priority activities being undertaken over the ...

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Pharmaceutical giant’s plan to end Australia’s reliance on Indian and Chinese medicines after COVID-19

2 May 2020 - Australia’s dangerous dependence on India and China to make vital medicines for the sick has come to ...

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TGA publishes more information about medicine formulations

30 April 2020 - To improve access to important medicine information, the Therapeutic Goods Administration now publishes additional formulation details ...

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The controversial malaria drug has been approved for an official trial

21 April 2020 - A massive new clinical trial has begun in Australia to test if an HIV or a ...

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Improved Consumer Medicine Information template

20 April 2020 - The Therapeutic Goods Regulations 1990 have been amended to support improved Consumer Medicine Information. ...

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Read about a new COVID-19 treatment study? It probably won't work.

6 April 2020 - Most new drugs that show promise as potential COVID-19 cures will not end up working, scientists ...

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