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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 23 Aug 2021
ATAGI update following weekly COVID-19 meeting (18 August 2021)
23 August 2021 - ATAGI met on Wednesday 18 August 2021 to review the latest developments relating to COVID-19 and COVID-19 ...
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 19 Aug 2021
COVID-19 vaccine weekly safety report (19 August 2021)
19 August 2021 - To 15 August 2021, approximately 15.3 million vaccine doses have been given in Australia – 9.9 million ...
Posted by Michael Wonder on 19 Aug 2021
TGA reduces timeframe for publishing adverse event reports
19 August 2021 - With strong public interest in adverse event reports relating to COVID-19 vaccinations, and improvements in our ...
Posted by Michael Wonder on 12 Aug 2021
Australian Technical Advisory Group on Immunisation weekly COVID-19 meeting - 11 August 2021 update
12 August 2021 - ATAGI met on Wednesday 11 August 2021 to review the latest developments relating to adverse events observed ...
Posted by Michael Wonder on 12 Aug 2021
Reclassification of software based medical devices
12 August 2021 - Recent changes to regulation of software based medical devices came into effect in early 2021, which ...
Posted by Michael Wonder on 12 Aug 2021
COVID-19 vaccine weekly safety report (12 August 2021)
12 August 2021 - To 8 August 2021, approximately 13.7 million vaccine doses have been given in Australia – 9.1 million ...
Posted by Michael Wonder on 11 Aug 2021
New Alzheimer's drug aducanumab is dividing doctors and patients, as the TGA weighs up its risk-benefit profile
12 August 2021 - After a decades-long career as a biology teacher, John Rodgers applies the strict logic of a ...
Posted by Michael Wonder on 11 Aug 2021
TGA head John Skerritt says NSW death toll would be much higher without AstraZeneca vaccine
11 August 2021 - The head of the national medical regulator says NSW would be recording “dozens” of covid deaths a ...
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 ...