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RSS FeedPosted by Michael Wonder on 18 Oct 2021
TGA provisional approval of Roche COVID-19 treatment, casirivimab with imdevimab (Ronapreve)
18 October 2021 - The TGA has provisionally approved the use of the Roche combination therapy, casirivimab + imdevimab (Ronapreve) ...
Posted by Michael Wonder on 14 Oct 2021
COVID-19 rapid antigen self-tests approved in Australia
13 October 2021 - The TGA has approved COVID-19 self-tests (home use tests) for supply in Australia from 1 November ...
Posted by Michael Wonder on 13 Oct 2021
Provisional determination granted to Pfizer's COVID-19 vaccine (Comirnaty) - proposed for use in children 5-11 years of age
13 October 2021 - On 12 October 2021, the Therapeutic Goods Administration granted a provisional determination to Pfizer in relation ...
Posted by Michael Wonder on 07 Oct 2021
BeiGene announces first regulatory approval in Australia for Brukinsa (zanubrutinib) for treatment of patients with Waldenström’s macroglobulinaemia
7 October 2021 - Represents Brukinsa’s second recent approval in the Asia-Pacific region, following October 1 approval in Singapore for treatment ...
Posted by Michael Wonder on 28 Sep 2021
TGA grants provisional determination to Roche COVID-19 treatment tocilizumab (Actemra)
28 September 2021 - On 27 September 2021, the TGA granted provisional determination to Roche in relation to the COVID-19 ...
Posted by Michael Wonder on 14 Sep 2021
Trodelvy approved by the TGA
14 September 2021 - Sacituzumab govitecan is a new treatment option for adult patients with unresectable locally advanced or metastatic triple negative ...
Posted by Michael Wonder on 14 Sep 2021
New therapy to treat advanced small cell lung cancer approved for Australian patients
14 September 2021 - Zepzelca approval granted under a provisional regulatory pathway. ...
Posted by Michael Wonder on 13 Sep 2021
Trodelvy approved following heroic efforts of breast cancer sufferer Alison Day
12 September 2021 - A dying woman’s selfless campaign will give Australian women battling a rare aggressive form of breast cancer ...
Posted by Michael Wonder on 06 Sep 2021
Statement on Moderna COVID-19 vaccine
6 September 2021 - Medicines Australia welcomes the TGA provisional approval for the COVID-19 vaccine, Spikevax (Moderna) for Australia. The ...
Posted by Michael Wonder on 04 Sep 2021
COVID-19 vaccine: Spikevax (elasomeran)
4 September 2021 - On 3 September 2021, the TGA granted provisional approval to Moderna Australia for the use of ...
Posted by Michael Wonder on 23 Aug 2021
TGA grants provisional determination to Celltrion Healthcare's anti-viral COVID-19 treatment regdanvimab
23 August 2021 - On 20 August 2021 the TGA granted provisional determination to Celltrion Healthcare in relation to regdanvimab. ...
Posted by Michael Wonder on 23 Aug 2021
TGA grants provisional determination to Roche combination COVID-19 treatment casirivimab and imdevimab (Ronapreve)
23 August 2021 - On 20 August 2021 the TGA granted provisional determination to Roche in relation to the combination ...
Posted by Michael Wonder on 22 Aug 2021
TGA approves new COVID-19 treatment for use in Australia
20 August 2021 - Australians with COVID-19 who are at risk of hospitalisation will now have access to an additional antibody ...
Posted by Michael Wonder on 20 Aug 2021
TGA provisionally approves GlaxoSmithKline's COVID-19 treatment sotrovimab (Xevudy)
20 August 2021 - Today, the Therapeutic Goods Administration granted provisional approval to GSK for its COVID-19 treatment - sotrovimab ...
Posted by Michael Wonder on 19 Aug 2021
TGA approves name change of COVID-19 Vaccine AstraZeneca to Vaxzevria
19 August 2021 - The Therapeutic Goods Administration has approved AstraZeneca's submission to change the name of its COVID-19 Vaccine ...