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RSS FeedPosted by Michael Wonder on 29 Nov 2021
TGA approves new medicines for patients with graft versus host disease
26 November 2021 - Rholistiq is Kadmon's first product to be approved in Australia. ...
Posted by Michael Wonder on 29 Nov 2021
Mayne Pharma and Mithra announce TGA approval of Nextstellis oral contraceptive
29 November 2021 - Mayne Pharma and Mithra Pharmaceuticals are very pleased to announce the TGA has approved the novel combined ...
Posted by Michael Wonder on 22 Nov 2021
TGA grants provisional determination to Grand Pacific for its COVID-19 protein-based subunit vaccine
22 November 2021 - The Therapeutic Goods Administration has granted provisional determination to Grand Pacific CRO (the Australian sponsor acting ...
Posted by Michael Wonder on 10 Nov 2021
Moderna's COVID-19 vaccine (Spikevax) - provisional determination granted for proposed use in children and booster shot for adults under evaluation
10 November 2021 - The TGA has granted a provisional determination to Moderna in relation to its COVID-19 vaccine, Spikevax. ...
Posted by Michael Wonder on 09 Nov 2021
TGA grants provisional determination to AstraZeneca for COVID-19 preventative treatment, tixagevimab and cilgavimab (Evusheld)
9 November 2021 - On 4 November 2021, the TGA granted provisional determination to AstraZeneca in relation to the COVID-19 treatment ...
Posted by Michael Wonder on 04 Nov 2021
TGA approves Illuccix for prostate cancer imaging
2 November 2021 - Telix is delighted to announce that the TGA has approved Illuccix (kit for the preparation of ...
Posted by Michael Wonder on 01 Nov 2021
TGA recognises two more COVID-19 vaccines not registered in Australia but used widely internationally
1 November 2021 - Today, the TGA determined that Covaxin (manufactured by Bharat Biotech, India) and BBIBP-CorV (manufactured by Sinopharm, China) ...
Posted by Michael Wonder on 27 Oct 2021
TGA approval for Pfizer COVID-19 vaccine booster dose
27 October 2021 - The TGA has approved a booster dose of the Pfizer COVID-19 vaccine for individuals 18 years ...
Posted by Michael Wonder on 27 Oct 2021
TGA approves booster doses of the Pfizer COVID-19 vaccine Comirnaty
27 October 2021 - The TGA has provisionally approved a booster dose of the Pfizer COVID-19 vaccine, Comirnaty, for individuals ...
Posted by Michael Wonder on 20 Oct 2021
TGA approves Brukinsa for another use
20 October 2021 - The second approval for zanubrutinib this month. ...
Posted by Michael Wonder on 19 Oct 2021
New medicine for breast cancer approved by the TGA
19 October 2021 - Enhertu has been approved for provisional registration. ...
Posted 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 ...