Blog
RSS FeedPosted by Michael Wonder on 26 Jul 2022
Henlius Hanquyou received TGA approval in Australia
26 July 2022 - Shanghai Henlius Biotech announced that the company's business partner Cipla has received the relevant registration certificates from ...
Posted by Michael Wonder on 26 Jul 2022
TGA gives a tick to Scemblix
26 July 2022 - Asciminib is an oral and potent inhibitor of Abelson non-receptor tyrosine kinases/breakpoint cluster region (ABL/BCR): ABL1 tyrosine ...
Posted by Michael Wonder on 25 Jul 2022
TGA provisionally approves the Biocelect (Novavax) COVID-19 vaccine, Nuvaxovid, for use in individuals aged 12-17 years
25 July 2022 - The TGA has provisionally approved the Biocelect (on behalf of Novavax) COVID-19 vaccine, Nuvaxovid, for use in ...
Posted by Michael Wonder on 21 Jul 2022
TGA approves Padcev
21 July 2022 - Enfortumab vedotin is an antibody-drug conjugate targeting nectin-4, an adhesion protein located on the surface of epithelial ...
Posted by Michael Wonder on 19 Jul 2022
TGA provisionally approves Moderna COVID-19 vaccine (Spikevax) for use in children from 6 months
19 July 2022 - The TGA has provisionally approved a paediatric dose of the Moderna COVID-19 vaccine, Spikevax, for use ...
Posted by Michael Wonder on 15 Jul 2022
TGA approves Grifols' Xembify
15 July 2022 - Xembify is yet another presentation of human immunoglobulin. ...
Posted by Michael Wonder on 06 Jul 2022
TGA grants provisional determinations to Pfizer for COVID-19 vaccines to target Omicron variant
6 July 2022 - On 5 July 2022, the TGA granted two provisional determinations to Pfizer in relation to COVID-19 ...
Posted by Michael Wonder on 30 Jun 2022
Provisional determination granted to Pfizer in relation to COVID 19 vaccine (Comirnaty) - for use in individuals 6 months up to 5 years
30 June 2022 - On 28 June 2022, the TGA granted a provisional determination to Pfizer Australia in relation to ...
Posted by Michael Wonder on 15 Jun 2022
TGA approval of Kimmtrak
15 June 2022 - Tebentafusp is a bi-specific fusion protein. ...
Posted by Michael Wonder on 14 Jun 2022
Novavax COVID-19 vaccine Nuvaxovid provisionally registered in Australia as a booster in individuals aged 18 and over
13 June 2022 - In Australia, Nuvaxovid is the first protein-based COVID-19 vaccine registered for use as a booster regardless ...
Posted by Michael Wonder on 08 Jun 2022
The UK MHRA, Australian TGA and Health Canada approve Kimmtrak (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma
8 June 2022 - Kimmtrak demonstrated statistically and clinically meaningful overall survival benefit, hazard ratio of 0.51, with median overall survival ...
Posted by Michael Wonder on 26 May 2022
TGA approves new medicine for patients with Cushing's syndrome
26 May 2022 - Osilodrostat phosphate is a cortisol synthesis inhibitor. ...
Posted by Michael Wonder on 09 May 2022
Product information update for COVID-19 treatment Xevudy (sotrovimab)
6 May 2022 - On 7 April 2022, the TGA announced receipt of an application from GSK for a higher (1000 ...
Posted by Michael Wonder on 28 Apr 2022
TGA grants provisional determination for the Moderna bivalent COVID-19 vaccine "Spikevax Bivalent Zero/Omicron"
28 April 2022 - On 27 April 2022, the TGA granted a provisional determination to Moderna in relation to its ...
Posted by Michael Wonder on 19 Apr 2022
iHealthScreen announces TGA approval for iPredict automated AI system for early diagnosis of diabetic retinopathy, age-related macular degeneration and glaucoma suspect
19 April 2022 - iHealthScreen is the first company in the USA to receive a CE certification, Australian Health approval, and ...