Blog
RSS FeedPosted by Michael Wonder on 22 Mar 2022
Prescription medicines: new or extended uses, or new combinations of registered medicines (February 2022)
22 March 2022 - The TGA approved a new indication for 7 medicines and one vaccine in February. ...
Posted by Michael Wonder on 22 Mar 2022
Hope for quadriplegics as ‘miracle treatment’ gets green light from regulator
21 March 2022 - In a major step forward for treating victims of paralysis, Australian regenerative medicine company Orthocell has ...
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 09 Mar 2022
TGA approves provisional determination for Biocelect for COVID-19 vaccine Nuvaxovid
10 March 2022 - The TGA has granted a second provisional determination to Biocelect (on behalf of Novavax) in relation ...
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 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 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
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 16 Feb 2022
Moderna's COVID-19 vaccine (Spikevax) provisionally approved for use in individuals 6 years and older
17 February 2022 - The TGA has provisionally approved the Moderna COVID-19 vaccine, Spikevax, for use in individuals aged 6 ...
Posted by Michael Wonder on 09 Feb 2022
TGA provisionally approves AstraZeneca's COVID-19 vaccine as booster dose
9 February 2022 - On 8 February 2022, the TGA provisionally approved a booster dose of the AstraZeneca COVID-19 vaccine, Vaxzevria, ...
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 28 Jan 2022
Pfizer's COVID-19 vaccine (Comirnaty) provisionally approved for use as a booster in individuals aged 16-17 years old
28 January 2022 - The Therapeutic Goods Administration has provisionally approved the Pfizer COVID-19 vaccine, Comirnaty for use as a ...
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 ...