Seattle Genetics announces Tukysa (tucatinib) approved within months for all countries participating in FDA’s Project Orbis initiative

12 August 2020 - Australia joins U.S., Switzerland, Canada and Singapore in approval of Tukysa for the treatment of patients with ...

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TGA approves new gene therapy from Novartis

13 August 2020 - Luxturna has been for the treatment of patients with inherited retinal dystrophy caused by pathological biallelic RPE65 ...

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Australian scientists say too early to pick COVID-19 vaccine race winner in advice to Federal Government

13 August 2020 - The leading group of scientists advising the Federal Government says there is still no clear frontrunner in ...

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Australia pins hopes on potential Oxford University COVID-19 vaccine

11 August 2020 - The Federal Government is positioning itself to secure and manufacture a COVID-19 vaccine in Australia, if ...

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Local doctor may have breakthrough coronavirus cure

11 August 2020 - Local doctor Thomas Borody has found what may be a cheap and easy treatment for COVID-19 patients ...

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Alkindi approved in Australia

10 August 2020 - Diurnal Group announces that Alkindi (hydrocortisone granules in capsules for opening) has been approved by the ...

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Australian start-ups push for bigger role in vaccine making

9 August 2020 - An Australian startup racing to develop a successful coronavirus vaccine has urged the federal government to ...

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Anavex Life Sciences receives TGA Special Access Scheme approval for Anavex 2-73 (blarcamesine) for Alzheimer’s disease patients

5 August 2020 - Compassionate use Special Access Scheme approval for Alzheimer’s patients to continue treatment with Anavex 2-73 (blarcamesine) after ...

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TGA approves new medicine for basal cell carcinoma

29 July 2020 - Cemiplimab (Libtayo) has been provisionally registered by the TGA. ...

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TGA approves Zeposia for patients with multiple sclerosis

27 July 2020 - Zeposia has been approved under the Black Triangle Scheme. ...

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Delays to the commencement of certain medical device regulatory changes

23 July 2020 - The Governor-General in Council has made regulations which delay the commencement of a number of medical ...

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Australia left in the dark as manufacturers race to make Oxford COVID-19 vaccine

22 July 2020 - Australia may have to compete with other nations to import supply of the University of Oxford's ...

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TGA publishes AusPAR for Vemlidy

21 July 2020 - AusPAR published within days of its provisional registration; why do other take years? ...

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Australian COVID researchers warn vaccines will have to be made overseas

20 July 2020 - Researchers at Monash University say if their COVID-19 vaccine is successful they will be forced to ...

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Actual and potential harm caused by medical software

16 July 2020 - TGA publishes a rapid literature review of safety and performance issues. ...

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