TGA - 2019 in review

14 January 2020 - According to the TGA, it approved 34 new chemical entities in 2019. ...

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Proposed changes to research and development tax incentive will discourage investment and undermine innovation

6 December 2019 - Medicines Australia is disappointed that proposed changes to the Research and Development Tax Incentive were tabled ...

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EpiPen Jr

2 December 2019 - Due to the critical nature of the ongoing EpiPen Jr shortage, the TGA is allowing one ...

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'Outrageous': banned breast implant maker flouts TGA and safety concerns

25 November 2019 - The Therapeutic Goods Administration is demanding answers from the manufacturer of a banned breast implant after ...

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Acalabrutinib receives TGA approval for CLL and SLL cancers

25 November 2019 - The Therapeutic Goods Administration has approved the use of acalabrutinib (Calquence) for the treatment of patients ...

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FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukaemia

21 November 2019 - Today, as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, ...

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TGA approved terminology for therapeutic goods

11 November 2019 - The Therapeutic Goods Administration develops and maintains approved terminology to ensure the accuracy and consistency of ...

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Proposed new classification rule for medical devices that administer medicines or biologicals by inhalation

24 October 2019 - The TGA thanks respondents who provided a submission in response to the public consultation paper Proposed new ...

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Annual performance statistics report: July 2018 to June 2019

21 October 2019 - At 30 June 2019 there were 88,788 therapeutic goods on the ARTG, including 31,987 new products added ...

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STA to market sarcoma drug in Australia, New Zealand and SE Asia following license deal

14 October 2019 - Specialised Therapeutics now filing for TGA approval. ...

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Progressing the long-term plan for stem cell research

2 October 2019 - This is the next step in the $150 million Stem Cell Therapies Mission, helping world-class Australian researchers ...

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TGA approves drug to fight ovarian cancer

26 September 2019 - Some women diagnosed with ovarian cancer could have their survival rates significantly increased after the Therapeutic ...

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Provisional approval of lenvatinib in combination with pembrolizumab for the treatment of advanced endometrial carcinoma

18 September 2019 - The Therapeutic Goods Administration has provisionally approved the use of lenvatinib (Lenvima) in combination with pembrolizumab ...

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Clinical trials to combat reproductive cancers

9 September 2019 - The Australian Government is investing up to $15 million in targeted clinical trials to improve treatments and ...

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$32 million available to support vital translational health

5 September 2019 - The Australian Government is opening the door for Australian researchers through a $32 million investment that will ...

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