Blog
RSS FeedPosted by Michael Wonder on 28 Nov 2022
Croma Australia, a subsidiary of Hugel Aesthetics, receives TGA approval in Australia for Letybo (letibotulinumtoxinA) for the treatment of glabellar lines
28 November 2022 - Approval is supported by positive results from three completed Phase 3 trials that enrolled more than 1000 ...
Posted by Michael Wonder on 28 Nov 2022
An open letter to doctors from the TGA
28 November 2022 - The TGA welcomes feedback and is committed to continuously improving processes and communications. ...
Posted 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 14 Sep 2022
Independent review of paracetamol overdose
14 September 2022 - The TGA has published an independent expert report examining the incidence of serious injury and death ...
Posted by Michael Wonder on 08 Sep 2022
'Long-term harm' for diabetics unable to access medication
8 September 2022 - Diabetic patients could need liver transplants down the line due to the shortage of a life-altering ...
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 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 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— ...
Posted by Michael Wonder on 13 Aug 2022
Restrictions put on diabetes drug Ozempic leave users feeling ‘fat shamed’
13 August 2022 - A drug that caused a buzz for its ability to help people shed kilos has now been ...