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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The TGA launches new tool to help sponsors find information on registering prescription medicines

3 September 2019 - Today the Therapeutic Goods Administration launched a new tool to assist users with finding information within ...

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Australian Public Assessment Reports for prescription medicines

28 August 2019 - TGA is reviewing the operation of transparency measures and are considering activities to increase transparency of ...

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Alimera announces Iluvien regulatory approval in Australia for the treatment of diabetic macular oedema

5 August 2019 - Specialised Therapeutics, an Australian biopharmaceutical company and Alimera’s distribution partner, to next seek national reimbursement. ...

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Fast track pathways for drug approvals: the Australian experience so far

1 August 2019 - In 2016, the Australian Government announced that the Therapeutic Goods Administration would establish two new pathways ...

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Reforms to the generic medicine market authorisation process

30 July 2019 - The TGA would like to thank respondents who provided submissions in response to the public consultation ...

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Intellectual property law amends will add to business uncertainty

26 July 2019 - Medicines Australia supports efforts to strengthen Australia’s Intellectual Property arrangements to be consistent with international best ...

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'I owe it everything': cancer drug approval win for rare cancers

23 July 2019 - Paul Hazelwood was told there was nothing else doctors could do to treat his rare terminal ...

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Pharma giant using loophole to falsely promote opioid pain relief product across Australia

10 July 2019 - Debbie Thompson is a grandmother of five who likes to crochet in her spare time. The ...

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These two brothers are living healthier lives, thanks to gene therapy

3 July 2019 - It has taken decades of work and billions of dollars, but Australia is now entering an ...

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Schedule of fees and charges

2 July 2019 - 2019-20 fees and charges schedule applies to applications submitted to the TGA on or after 1 July ...

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International work-sharing Initiative - niraparib (Zejula)

1 July 2019 - The TGA has approved a new drug for the treatment of some ovarian, fallopian tube, or ...

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Cost recovery implementation statement

21 June 2019 - The cost recovery implementation statement outlines the TGA's regulatory costs and provides detailed information on TGA's ...

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