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RSS FeedPosted by Michael Wonder on 23 Aug 2021
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 ...
Posted by Michael Wonder on 22 Aug 2021
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 ...
Posted by Michael Wonder on 20 Aug 2021
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 ...
Posted by Michael Wonder on 19 Aug 2021
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 ...
Posted by Michael Wonder on 11 Aug 2021
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 ...
Posted by Michael Wonder on 10 Aug 2021
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 ...
Posted by Michael Wonder on 09 Aug 2021
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 ...
Posted by Michael Wonder on 26 Jun 2021
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, ...
Posted by Michael Wonder on 23 Jun 2021
TGA approves first generic pomalidomide
23 June 2021 - The TGA has approved first generic version of Celgene's Pomalyst. ...
Posted by Michael Wonder on 09 Jun 2021
New Alzheimer’s drug unlikely to be approved in Australia soon, say experts
9 June 2021 - A controversial new drug that has offered hope to Alzheimer’s sufferers by slowing cognitive decline still ...
Posted by Michael Wonder on 09 Jun 2021
Glaukos Announces Australia’s TGA regulatory approval for Preserflo MicroShunt
8 June 2021 - Glaukos Corporation today announced that the TGA has granted regulatory approval for the Preserflo MicroShunt intended for ...
Posted by Michael Wonder on 25 May 2021
TGA approves more flexible storage conditions for Pfizer-BioNTech COVID-19 vaccine
24 May 2021 - Today, the TGA approved an application from Pfizer to change its current storage conditions for its ...
Posted by Michael Wonder on 24 May 2021
Gilead withdraws submission for Jyseleca
24 May 2021 - Decision should not come as a major surprise given FDA rejection last year. ...
Posted by Michael Wonder on 13 May 2021
Provisional determination granted to Pfizer in relation to COVID 19 vaccine (Comirnaty) - for use in individuals 12 years of age and older
13 May 2021 - On 11 May 2021, the Therapeutic Goods Administration granted a provisional determination to Pfizer Australia in ...
Posted by Michael Wonder on 12 May 2021
TGA approves Octapharma's Cutaquig
12 May 2021 - The TGA has deemed it to be a new biological entity. Others will beg to differ. ...