Blog
RSS FeedPosted by Michael Wonder on 28 Jan 2025
Apellis receives approval of Syfovre (pegcetacoplan) in Australia for geographic atrophy
27 January 2025 - Apellis Pharmaceuticals announced today that the TGA has approved Syfovre (pegcetacoplan) for the every-other-month treatment of adult ...
Posted by Michael Wonder on 15 Dec 2024
ARS Pharmaceuticals announces filings for approval of neffy in China, Japan and Australia
12 December 2024 - Licensing partners in key Asia Pacific countries have filed for approval of neffy (epinephrine nasal spray) ...
Posted by Michael Wonder on 17 Oct 2024
Experts label TGA’s decision to not register Alzheimer’s drug ‘extremely disappointing’
16 October 2024 - A drug that could hold the key to delaying symptoms of devastating Alzheimer’s disease will not be ...
Posted by Michael Wonder on 03 Oct 2024
KalVista announces the submission of additional marketing authorisation applications for sebetralstat for the oral on-demand treatment of hereditary angioedema
30 September 2024 - If approved, sebetralstat will be the first, oral on-demand treatment for HAE. ...
Posted by Michael Wonder on 16 Apr 2024
Norgine submits marketing authorisation application via Project Orbis for eflornithine (difluoromethylornithine) in high-risk neuroblastoma
15 April 2024 - Norgine today announced its first marketing authorisation application submissions on 10 April 2024, seeking approval for eflornithine ...
Posted by Michael Wonder on 03 Dec 2023
Junshi Biosciences announces new chemical entity application for toripalimab accepted by Australia’s TGA
1 December 2023 - Shanghai Junshi Biosciences announced that the TGA has accepted the new chemical entity application for toripalimab in ...
Posted by Michael Wonder on 01 Sep 2023
Celltrion applies for Australian approval for Stelara biosimilar
31 August 2023 - Celltrion said it has completed a marketing authorisation application for CT-P43, a biosimilar referencing Stelara (ustekinumab) ...
Posted by Michael Wonder on 23 Jan 2023
TGA commences evaluation of Moderna COVID-19 vaccine (Spikevax) for potential transition to full registration
20 January 2023 - The TGA has commenced evaluation of an application from Moderna to transition its COVID-19 vaccine, Spikevax, ...
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 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 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 03 Aug 2022
COVID-19 vaccines undergoing evaluation (3 August 2022)
3 August 2022 - The TGA has published a list (table) of the COVID-19 vaccines currently under evaluation by the agency. ...
Posted by Michael Wonder on 03 Aug 2022
TGA commences evaluation of Pfizer's COVID-19 vaccine (Comirnaty) for children aged 6 months to less than 5 years
3 August 2022 - The TGA has commenced evaluation of an application from Pfizer to extend the use of its ...
Posted by Michael Wonder on 06 Jun 2022
Medigen applies for Australian vaccine approval
7 June 2022 - Medigen Vaccine Biologics has applied to the Australian medicines regulator for provisional approval of its COVID-19 ...