Deciphera announces Australian Therapeutic Goods Administration’s approval of Qinlock (ripretinib) for the treatment of fourth-line gastro-intestinal stromal tumour

14 July 2020 - Qinlock is the first approved tyrosine kinase inhibitor designed specifically for GIST regardless of patients’ mutational status. ...

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Gilead rushes to meet remdesivir demand as virus pressures grow

15 July 2020 - Global pharmaceuticals giant Gilead has flagged the supply of its coronavirus treatment remdesivir will be constrained ...

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TGA publishes more details on its approval of COVID-19 medicine Veklury

13 July 2020 - Remdesivir granted conditional approval in record time. ...

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Australian vaccine trial starts today

13 July 2020 - Australian scientists are on track to deliver a COVID-19 vaccine this year, with the start on Monday ...

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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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Cochlear calls for low risk health apps to be exempt from TGA register

3 July 2020 - Hearing implant giant Cochlear has called for some low risk health apps to be exempt from ...

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Gilead donates COVID-19 drug remdesivir to Australia’s medical stockpile after US buys up supply

2 July 2020 - The US pharmaceutical giant Gilead has donated a supply of the anti-viral medication remdesivir to Australia’s ...

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Reduced annual charges for medical devices listed on the prostheses list

2 July 2020 - In response to the suspension of elective surgery due to COVID-19 and the significant impact this has ...

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Medicines Australia welcomes support for national harmonisation of clinical trials

30 June 2020 - Medicines Australia welcomes the announcement from the Minister for Health, the Hon Greg Hunt MP, during ...

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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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Submissions received: scope of regulated software based medical devices

15 June 2020 - A total of 48 submissions were received in response to the Scope of Regulated Software based products ...

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The University of Queensland, CEPI and CSL partner to advance development and manufacture of COVID-19 vaccine candidate

5 June 2020 - A vaccine is anticipated to be available in 2021 if clinical trials are successful. ...

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