Blog
RSS FeedPosted by Michael Wonder on 22 Mar 2022
Prescription medicines: applications under evaluation (March 2022)
22 March 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...
Posted by Michael Wonder on 18 Mar 2022
Australian cancer patients to get improved access to clinical trials
17 March 2022 - Australian cancer patients will get improved access to local clinical trials through a new public-private partnership ...
Posted by Michael Wonder on 17 Mar 2022
Backing life-saving local cancer drug development
17 March 2022 - Joint media release with the Minister for Health and Aged Care the Hon Greg Hunt MP. ...
Posted by Michael Wonder on 15 Mar 2022
Single dose Kozenis (tafenoquine) approved for children with Plasmodium vivax malaria by Australian Therapeutic Goods Administration
14 March 2022 - Novel paediatric relapse prevention treatment marks a major contribution towards malaria elimination efforts. ...
Posted by Michael Wonder on 12 Mar 2022
Antengene announces Xpovio approved by the TGA in Australia for the treatment of relapsed and/or refractory multiple myeloma and triple class-refractory multiple myeloma
10 March 2022 - Xpovio is the first of a new class of SINE (selective inhibitor of nuclear export) medicines. ...
Posted 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 ...