Celltrion applies for Australian approval for Stelara biosimilar

31 August 2023 - Celltrion said it has completed a marketing authorisation application for CT-P43, a biosimilar referencing Stelara (ustekinumab) ...

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Peter Mac increases manufacturing centre for gene therapy bringing new hope to cancer patients

25 July 2023 - Australia’s first biomedical manufacturing facility has opened in Melbourne and will boost lifesaving therapy for cancer patients ...

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Idefirix (imlifidase) receives provisional approval in Australia as desensitisation treatment in highly sensitised patients prior to kidney transplantation

11 July 2023 - Regulatory milestone marks the first time Idefirix has been approved in kidney transplantation from both living ...

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TGA decision on access to medical terminations

11 July 2023 - The Government welcomes the TGA’s decision to remove a number of restrictions on health professionals who ...

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Moderna announces global regulatory submissions for its respiratory syncytial virus (RSV) vaccine, mRNA-1345

5 July 2023 - Moderna has submitted marketing authorization applications for the investigational RSV vaccine, mRNA-1345, with the European Medicines Agency, ...

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Lymphoma therapy now approved for Australian patients with diffuse large B-cell lymphoma

28 June 2023 - Recent five-year follow-up data from Phase 2 L-MIND investigation showed patients treated with Minjuvi had prolonged, ...

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‘Future of cancer treatment’ has just been approved

6 June 2023 - Australian scientists pioneering a new type of therapy, which re-engineers a patient’s own T-cells, could result in ...

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TGA supports MHRA’s new international recognition framework for medicines

2 June 2023 - As a trusted regulatory partner, TGA is committed to support the new international recognition framework that MHRA ...

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TGA approves pathway for more plasma donors

30 May 2023 - The Government welcomes the Therapeutic Goods Administration’s approval of a ‘plasma pathway’, allowing a larger pool of ...

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‘A victim of its own success’: inside the great Ozempic shortage

26 May 2023 - The drug is approved in Australia to treat type 2 diabetes but people have flocked to it ...

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ATAGI advice on the preferential use of bivalent COVID-19 vaccines for primary vaccination of people aged 12 years or older

30 May 2023 - ATAGI has made recommendations on the use of bivalent COVID-19 vaccines as a primary course. ...

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Moderna’s COVID-19 vaccine Spikevax receives approval for full registration

24 April 2023 - On 21 April, the TGA approved Moderna Australia’s application to transition its COVID-19 vaccine, Spikevax (elasomeran), ...

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COVID-19 vaccine safety report (6 April 2023)

6 April 2023 - To 2 April 2023, more than 44 million doses of Comirnaty (Pfizer) mRNA vaccines have been administered in ...

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AstraZeneca vaccine discontinued by Federal Government

5 April 2023 - One of the first COVID-19 jabs offered to Australians has been quietly discontinued, the Federal Government has ...

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TGA’s new powers will help reduce the impact of medicine shortages on patients

24 March 2023 - From 22 March 2023, the TGA can approve the temporary import or supply of an overseas approved ...

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