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 ...

Read more →

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) ...

Read more →

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, ...

Read more →

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 ...

Read more →

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 ...

Read more →

Prescription medicines: applications under evaluation

24 August 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...

Read more →

Roche withdraws application for Tecentriq

25 August 2022 - Publication of AusPAR reveals the withdrawal of the application in July 2021. ...

Read more →

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. ...

Read more →

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 ...

Read more →

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 ...

Read more →

Prescription medicines: applications under evaluation (May 2022)

26 May 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...

Read more →

TGA commences evaluation of Moderna COVID-19 vaccine (Spikevax) for children aged 6 months to 5 years old

13 May 2022 - The TGA has received, and immediately commenced evaluation of, an application from Moderna to extend the ...

Read more →

Prescription medicines: applications under evaluation (April 2022)

19 April 2022 - The TGA has updated its list of applications for new medicines or new uses for existing medicines ...

Read more →

TGA receives application for an increased dose of GlaxoSmithKline’s COVID-19 treatment sotrovimab (Xevudy) for the BA.2 omicron sublineage

7 April 2022 - The TGA has received an application from GSK for a higher (1,000 mg) dose of its ...

Read more →

Prescription medicines: applications under evaluation (March 2022)

22 March 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...

Read more →