15 April 2024 - Norgine today announced its first marketing authorisation application submissions on 10 April 2024, seeking approval for eflornithine ...
1 December 2023 - Shanghai Junshi Biosciences announced that the TGA has accepted the new chemical entity application for toripalimab in ...
31 August 2023 - Celltrion said it has completed a marketing authorisation application for CT-P43, a biosimilar referencing Stelara (ustekinumab) ...
20 January 2023 - The TGA has commenced evaluation of an application from Moderna to transition its COVID-19 vaccine, Spikevax, ...
24 November 2022 - Obtained marketing approval on the 23rd (local time) from the TGA of Australia for the indication of ...
30 August 2022 - The TGA has updated its list of the applications it has received for COVID-19 vaccines using the ...
24 August 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...
25 August 2022 - Publication of AusPAR reveals the withdrawal of the application in July 2021. ...
3 August 2022 - The TGA has published a list (table) of the COVID-19 vaccines currently under evaluation by the agency. ...
3 August 2022 - The TGA has commenced evaluation of an application from Pfizer to extend the use of its ...
7 June 2022 - Medigen Vaccine Biologics has applied to the Australian medicines regulator for provisional approval of its COVID-19 ...
26 May 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...
13 May 2022 - The TGA has received, and immediately commenced evaluation of, an application from Moderna to extend the ...
19 April 2022 - The TGA has updated its list of applications for new medicines or new uses for existing medicines ...
7 April 2022 - The TGA has received an application from GSK for a higher (1,000 mg) dose of its ...