TGA statement on UK government emergency use authorisation related to the COVID-19 vaccine BNT162b2 supplied by Pfizer and BioNTech

2 December 2020 - The TGA notes the emergency use authorisation related to the COVID-19 vaccine BNT162b2 supplied by Pfizer ...

Read more →

TGA announces approval of new medicine from ASX listed company

26 November 2020 - Afamelanotide acetate (Scenesse) was approved on 22 October 2020. ...

Read more →

Medical trial delays see Australians wait for rare disease treatment

25 November 2020 - Patients with rare diseases are entering ‘random lottery’ draws for clinical trials because Australia is too slow ...

Read more →

Australia's coronavirus vaccination program to start from March

25 November 2020 - The federal government says Australia is on track to deliver the first vaccines in March. ...

Read more →

First batch of Oxford University’s vaccine for COVID-19 ready by New Year’s Day

21 November 2020 - The Australian manufacturer of the Oxford University-AstraZeneca COVID-19 vaccine has revealed when the first doses will ...

Read more →

TGA grants third provisional determination for a COVID-19 vaccine

18 November 2020 - On 16 November 2020 the TGA granted a provisional determination to Janssen Cilag in relation to ...

Read more →

Vaccines including for COVID-19 will be made in new Australian plant

15 November 2020 - A state-of-the-art facility focusing on producing vaccines for things like COVID-19 and snake bites will be built ...

Read more →

Coronavirus: the vaccine is coming, so who should get it first?

13 November 2020 - A specific class of “superspreaders” should be top of the queue for any COVID-19 vaccine once ...

Read more →

Coronavirus: vaccine rollout for five million Aussies tipped for March

11 November 2020 - The regulator of medicines in Australia has confirmed it expects to be able to approve the ...

Read more →

Pfizer vaccine will be shipped in 'Eskies' as vaccines get preliminary approval

11 November 2020 - The Pfizer COVID-19 vaccine will be moved around Australia in specialised Eskies as part of a ...

Read more →

Therapeutic Goods Administration gives green light for early Pfizer vaccine

11 November 2020 - The nation’s medicines regulator has paved the way for an early ­release of Pfizer’s breakthrough COVID-19 ...

Read more →

Mirum Pharmaceuticals broadens Expanded Access Program for maralixibat in Alagille syndrome to Europe and Australia

5 November 2020 - Maralixibat Expanded Access Program now available for patients with pruritus associated with Alagille syndrome in Australia and ...

Read more →

Made in Melbourne: lab to start producing promising coronavirus vaccine

8 November 2020 - Global biotech company CSL will begin manufacturing millions of vials of one of the most promising ...

Read more →

New drug for gastro-intestinal stromal tumours to be launched in Australia, New Zealand and South East Asia following distribution agreement

5 November 2020 - Qinlock is already approved by the TGA and US FDA. ...

Read more →

Clinical Trial Exemption (CTX) scheme renamed as Clinical Trial Approval (CTA) scheme

6 November 2020 - The TGA has changed the name of the Clinical Trial Exemption (CTX) scheme to the Clinical ...

Read more →