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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 06 Sep 2022
NASWSI and Project Orbis - are they essentially the same?
7 September 2022 - We compare and contrast the two initiatives to bring new medicines to the market faster. ...
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 03 Sep 2022
ATAGI update following weekly COVID-19 meeting (31 August 2022)
2 September 2022 - An update from the Australian Technical Advisory Group on Immunisation following their weekly meeting on 31 August ...
Posted by Michael Wonder on 30 Aug 2022
TGA launches new look website
30 August 2022 - The new look website has gone live this evening. ...
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 30 Aug 2022
COVID-19 vaccines undergoing evaluation (30 August 2022)
30 August 2022 - The TGA has updated its list of the applications it has received for COVID-19 vaccines using the ...
Posted by Michael Wonder on 26 Aug 2022
ATAGI update following weekly COVID-19 meeting (24 August 2022)
26 August 2022 - On Wednesday 24 August 2022, ATAGI met to consider the latest developments relating to COVID-19 immunisation. ...
Posted by Michael Wonder on 25 Aug 2022
Novavax vaccine for adolescents aged 12-17 years
25 August 2022 - The Australian Technical Advisory Group on Immunisation has evaluated data on immunogenicity, efficacy, safety, and international ...
Posted by Michael Wonder on 25 Aug 2022
COVID-19 vaccine safety report (25 August 2022)
25 August 2022 - To 21 August 2022, the TGA has received 674 reports which have been assessed as likely to ...
Posted by Michael Wonder on 24 Aug 2022
Prescription medicines: applications under evaluation
24 August 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...
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 21 Aug 2022
Ozempic restrictions for weight loss ‘unfair’, obesity expert says
21 August 2022 - A diabetes drug proven to help with weight loss has been limited for use in diabetics only— ...