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RSS FeedPosted by Michael Wonder on 07 Sep 2022
First combination COVID-19 and influenza self-tests approved for Australia
7 September 2022 - The TGA has approved the first two nasal combination self-tests (for use at home) that detect ...
Posted by Michael Wonder on 05 Sep 2022
International work-sharing - first medicines approved by all five Access Consortium regulators
2 September 2022 - The TGA has approved two new medicines as part of the Access New Active-Substance Work-Sharing Initiative. ...
Posted by Michael Wonder on 30 Aug 2022
TGA provisionally approves Moderna bivalent COVID-19 vaccine for use as a booster dose in adults
30 August 2022 - On 29 August 2022, the TGA provisionally approved Moderna's bivalent COVID-19 vaccine, elasomeran with imelasomeran (Spikevax Bivalent ...
Posted by Michael Wonder on 24 Aug 2022
Roche withdraws application for Tecentriq
25 August 2022 - Publication of AusPAR reveals the withdrawal of the application in July 2021. ...
Posted by Michael Wonder on 23 Aug 2022
Veru granted expedited provisional registration regulatory pathway for sabizabulin treatment in hospitalised COVID-19 patients by Australia’s TGA
22 August 2022 - Veru today announced that Australia’s TGA has determined that sabizabulin treatment in hospitalised COVID-19 patients at ...
Posted by Michael Wonder on 22 Aug 2022
TGA grants provisional determination for sabizabulin for the treatment of COVID-19
22 August 2022 - On 19 August 2022, the TGA granted a provisional determination to Adjutor Healthcare for a new ...
Posted by Michael Wonder on 04 Aug 2022
TGA says go to BioMarin for Voxzogo
4 August 2022 - Vosoritide is a modified type C natriuretic peptide. ...
Posted by Michael Wonder on 01 Aug 2022
TGA approves new medicine for NSCLC patients with an EGFR exon 20 mutation
1 August 2020 - First medicine approved by the TGA for this mutation. ...
Posted by Michael Wonder on 26 Jul 2022
Henlius Hanquyou received TGA approval in Australia
26 July 2022 - Shanghai Henlius Biotech announced that the company's business partner Cipla has received the relevant registration certificates from ...
Posted by Michael Wonder on 26 Jul 2022
TGA gives a tick to Scemblix
26 July 2022 - Asciminib is an oral and potent inhibitor of Abelson non-receptor tyrosine kinases/breakpoint cluster region (ABL/BCR): ABL1 tyrosine ...
Posted by Michael Wonder on 25 Jul 2022
TGA provisionally approves the Biocelect (Novavax) COVID-19 vaccine, Nuvaxovid, for use in individuals aged 12-17 years
25 July 2022 - The TGA has provisionally approved the Biocelect (on behalf of Novavax) COVID-19 vaccine, Nuvaxovid, for use in ...
Posted by Michael Wonder on 21 Jul 2022
TGA approves Padcev
21 July 2022 - Enfortumab vedotin is an antibody-drug conjugate targeting nectin-4, an adhesion protein located on the surface of epithelial ...
Posted by Michael Wonder on 19 Jul 2022
TGA provisionally approves Moderna COVID-19 vaccine (Spikevax) for use in children from 6 months
19 July 2022 - The TGA has provisionally approved a paediatric dose of the Moderna COVID-19 vaccine, Spikevax, for use ...
Posted by Michael Wonder on 15 Jul 2022
TGA approves Grifols' Xembify
15 July 2022 - Xembify is yet another presentation of human immunoglobulin. ...
Posted by Michael Wonder on 06 Jul 2022
TGA grants provisional determinations to Pfizer for COVID-19 vaccines to target Omicron variant
6 July 2022 - On 5 July 2022, the TGA granted two provisional determinations to Pfizer in relation to COVID-19 ...