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RSS FeedPosted by Michael Wonder on 25 Nov 2022
Hugel's 'Letybo' first in Korea to obtain marketing approval from Australia
24 November 2022 - Obtained marketing approval on the 23rd (local time) from the TGA of Australia for the indication of ...
Posted by Michael Wonder on 17 Nov 2022
Amarin announces Vazkepa (icosapent ethyl) approved by the TGA in Australia
15 November 2022 - Marks fifth regulatory approval for Vascepa/Vazkepa franchise in key international markets in 2022. ...
Posted by Michael Wonder on 16 Nov 2022
TGA grants provisional determination to Pfizer’s COVID-19 bivalent (Comirnaty Bivalent Omicron BA.4/BA.5) booster dose vaccine
16 November 2022 - On 15 November 2022, the TGA granted a provisional determination to Pfizer’s bivalent COVID-19 vaccine candidate: tozinameran ...
Posted by Michael Wonder on 28 Oct 2022
TGA provisionally approves Pfizer bivalent COVID-19 vaccine for use as a booster dose in adults
28 October 2022 - On 27 October 2022, the TGA provisionally approved Pfizer’s bivalent COVID-19 vaccine, tozinameran and riltozinameran (COMIRNATY Original/Omicron ...
Posted by Michael Wonder on 20 Oct 2022
TGA provisionally approves Moderna’s COVID-19 vaccine for use as a booster dose in individuals 12 years and older
20 October 2022 - On 19 October 2022, the TGA provisionally approved Moderna's COVID-19 vaccine, Spikevax (elasomeran), for use as ...
Posted by Michael Wonder on 30 Sep 2022
TGA grants provisional determination to Moderna’s COVID-19 bivalent (Original plus Omicron BA.4/BA.5) booster dose vaccine
30 September 2022 - On 28 September 2022, the TGA granted a provisional determination to Moderna's bivalent COVID-19 vaccine candidate: elasomeran ...
Posted by Michael Wonder on 29 Sep 2022
TGA provisionally approves Pfizer’s COVID-19 vaccine, Comirnaty (tozinameran) for use in children aged 6 months to less than 5 years
29 September 2022 - On 29 September 2022, the TGA provisionally approved a paediatric dose of Pfizer’s COVID-19 vaccine, Comirnaty (tozinameran), ...
Posted by Michael Wonder on 21 Sep 2022
TGA provisionally approves Pfizer's COVID-19 vaccine, Comirnaty (tozinameran), for use as a booster dose in individuals 5 years and older
21 September 2022 - On 20 September 2022, the TGA provisionally approved Pfizer's COVID-19 vaccine, Comirnaty (tozinameran) for use as ...
Posted 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. ...