Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 13 Apr 2022
TGA approves Lumakras
13 April 2022 - Sotorasib is a Kirsten rat sarcoma (KRAS) G12C inhibitor, which covalently and irreversibly binds to the unique ...
Posted by Michael Wonder on 12 Apr 2022
TGA approves new medicine for patients with SLE
12 April 2022 - Anifrolumab is a human immunoglobulin G1 kappa monoclonal antibody that binds to subunit 1 of the type ...
Posted by Michael Wonder on 08 Apr 2022
TGA approved Yuflyma
8 April 2022 - The TGA has approved yet another adalimumab biosimilar. ...
Posted by Michael Wonder on 08 Apr 2022
TGA provisionally approves Pfizer’s COVID-19 vaccine (Comirnaty), for use as a booster for individual aged 12–15 years old
8 April 2022 - The TGA has provisionally approved the Pfizer Australia Pty Ltd COVID-19 vaccine, Comirnaty, for use as a ...
Posted by Michael Wonder on 07 Apr 2022
TGA approves yet another new medicine for patients with psoriasis
7 April 2022 - Bimekizumab is a humanised immunoglobulin G1 kappa monoclonal antibody. It has two identical antigen binding regions that ...
Posted by Michael Wonder on 04 Apr 2022
Here comes yet another new medicine for patients with MS
4 April 2022 - The TGA has approved Vumerity (diroximel fumarate). ...
Posted by Michael Wonder on 24 Mar 2022
TGA approves new medicine for patients with multiple sclerosis
24 March 2022 - Ponesimod is a sphingosine 1 phosphate receptor 1 modulator. ...