TGA grants provisional determination to Roche COVID-19 treatment tocilizumab (Actemra)

28 September 2021 - On 27 September 2021, the TGA granted provisional determination to Roche in relation to the COVID-19 ...

Read more →

Trodelvy approved by the TGA

14 September 2021 - Sacituzumab govitecan is a new treatment option for adult patients with unresectable locally advanced or metastatic triple negative ...

Read more →

New therapy to treat advanced small cell lung cancer approved for Australian patients

14 September 2021 - Zepzelca approval granted under a provisional regulatory pathway. ...

Read more →

Trodelvy approved following heroic efforts of breast cancer sufferer Alison Day

12 September 2021 - A dying woman’s selfless campaign will give Australian women battling a rare aggressive form of breast cancer ...

Read more →

Statement on Moderna COVID-19 vaccine

6 September 2021 - Medicines Australia welcomes the TGA provisional approval for the COVID-19 vaccine, Spikevax (Moderna) for Australia. The ...

Read more →

COVID-19 vaccine: Spikevax (elasomeran)

4 September 2021 - On 3 September 2021, the TGA granted provisional approval to Moderna Australia for the use of ...

Read more →

TGA grants provisional determination to Celltrion Healthcare's anti-viral COVID-19 treatment regdanvimab

23 August 2021 - On 20 August 2021 the TGA granted provisional determination to Celltrion Healthcare in relation to regdanvimab. ...

Read more →

TGA grants provisional determination to Roche combination COVID-19 treatment casirivimab and imdevimab (Ronapreve)

23 August 2021 - On 20 August 2021 the TGA granted provisional determination to Roche in relation to the combination ...

Read more →

TGA approves new COVID-19 treatment for use in Australia

20 August 2021 - Australians with COVID-19 who are at risk of hospitalisation will now have access to an additional antibody ...

Read more →

TGA provisionally approves GlaxoSmithKline's COVID-19 treatment sotrovimab (Xevudy)

20 August 2021 - Today, the Therapeutic Goods Administration granted provisional approval to GSK for its COVID-19 treatment - sotrovimab ...

Read more →

TGA approves name change of COVID-19 Vaccine AstraZeneca to Vaxzevria

19 August 2021 - The Therapeutic Goods Administration has approved AstraZeneca's submission to change the name of its COVID-19 Vaccine ...

Read more →

TGA grants provisional determination to MSD's anti-viral COVID-19 treatment molnupiravir

10 August 2021 - On 9 August 2021 the Therapeutic Goods Administration granted provisional determination to MSD in relation to ...

Read more →

Jason Falinski slams TGA’s slow Moderna Covid vaccine approval

10 August 2021 - The TGA took eight months to approve the Moderna Covid-19 vaccine in Australia despite its use in ...

Read more →

TGA provisionally approves Moderna’s COVID-19 vaccine

9 August 2021 - Today, the Therapeutic Goods Administration, granted provisional approval to Moderna Australia for its COVID-19 vaccine—Spikevax (elasomeran)—making ...

Read more →

TGA grants third provisional approval to COVID-19 vaccine: Janssen

25 June 2021 - On 25 June 2021, the TGA granted provisional approval to Janssen-Cilag for its COVID-19 vaccine Janssen, ...

Read more →