Blog
RSS FeedPosted by Michael Wonder on 07 Mar 2022
TGA approves Sogroya
8 March 2022 - Somapacitan is a long‑acting recombinant human growth hormone derivative. ...
Posted by Michael Wonder on 06 Mar 2022
Australian COVID nasal spray not on shop shelves amid TGA dispute
4 March 2022 - Melbourne start-up Starpharma is at loggerheads with the medicines regulator over the approvals process for its ...
Posted by Michael Wonder on 03 Mar 2022
Jemperli approved by the TGA
2 March 2022 - Dostarlimab is an anti-programmed cell death protein 1 immunoglobulin G4 humanised monoclonal antibody, derived from a stable ...
Posted by Michael Wonder on 28 Feb 2022
Prescription medicines: applications under evaluation (February 2022)
25 February 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...
Posted by Michael Wonder on 25 Feb 2022
TGA provisionally approves AstraZeneca's combination therapy (tixagevimab and cilgavimab, Evusheld) - for pre-exposure prevention (prophylaxis) of COVID-19
25 February 2022 - On 24 February 2022, the TGA granted provisional approval to AstraZeneca for its tixagevimab and cilgavimab ...
Posted by Michael Wonder on 22 Feb 2022
Controversial Alzheimer’s drug under TGA review ‘should not be approved’
21 February 2022 - Patients will be put at risk and taxpayers will face a significant economic burden if aducanumab receives ...
Posted by Michael Wonder on 22 Feb 2022
TGA approves Rybelsus
22 February 2022 - Rybelsus is a new formulation of semaglutide. ...
Posted by Michael Wonder on 17 Feb 2022
Empaveli approved by the TGA
17 February 2022 - First TGA approval for newcomer Apellis. ...
Posted by Michael Wonder on 14 Feb 2022
Anxiety mounts for Australian patients as supply chain crunch hits another arthritis drug
14 February 2022 - Patients are reckoning with major shortages of a second rheumatoid arthritis drug in Australia, with manufacturing ...
Posted by Michael Wonder on 09 Feb 2022
Evolus receives acceptance of submission in Australia, a pivotal step in approval process for Nuceiva
8 February 2022 - Evolus today announced the acceptance of its submission to the Australian TGA for regulatory approval of Nuceiva ...
Posted by Michael Wonder on 05 Feb 2022
TGA approves provisional determination for Gilead for COVID-19 treatment, Veklury (remdesivir), for proposed use in children and adults who are at risk of progressing to severe COVID-19
5 February 2022 - The TGA has granted a second provisional determination to Gilead in relation to its COVID-19 treatment, ...
Posted by Michael Wonder on 27 Jan 2022
TGA approves Tepmetko for patients with non-small-cell lung cancer
27 January 2022 - Tepotinib (Tepmetko) has provisional approval in Australia for the treatment of adult patients with locally advanced or ...
Posted by Michael Wonder on 20 Jan 2022
Statement on the arrival of the Novavax vaccine and COVID-19 pills
20 January 2022 - Medicines Australia welcomes the TGA’s provisional approval for the Novavax COVID-19 vaccine and the provisional approval ...
Posted by Michael Wonder on 20 Jan 2022
Two anti-viral COVID-19 treatments approved
20 January 2022 - The Australian Government welcomes the Therapeutic Goods Administration’s provisional approval of the first oral treatments for COVID-19 ...
Posted by Michael Wonder on 19 Jan 2022
TGA provisionally approves two oral COVID-19 treatments, molnupiravir (Lagevrio) and nirmatrelvir and ritonavir (Paxlovid)
20 January 2022 - The TGA has granted provisional approval to two oral COVID-19 treatments: Paxlovid (nirmatrelvir and ritonavir, Pfizer) ...