Blog
RSS FeedPosted 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 19 Apr 2022
Prescription medicines: applications under evaluation (April 2022)
19 April 2022 - The TGA has updated its list of applications for new medicines or new uses for existing medicines ...
Posted by Michael Wonder on 14 Apr 2022
COVID-19 vaccine weekly safety report (14 April 2022)
14 April 2022 - To 10 April 2022, the TGA has received 528 reports which have been assessed as likely to ...
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 09 Apr 2022
ATAGI statement on use of booster doses in adolescents aged 12-15 years
8 April 2022 - A statement from the ATAGI on booster doses in adolescents aged 12-15 years. ...
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 receives application for an increased dose of GlaxoSmithKline’s COVID-19 treatment sotrovimab (Xevudy) for the BA.2 omicron sublineage
7 April 2022 - The TGA has received an application from GSK for a higher (1,000 mg) dose of its ...
Posted by Michael Wonder on 07 Apr 2022
COVID-19 vaccine weekly safety report (7 April 2022)
7 April 2022 - To 3 April 2022, the TGA has received 511 reports which have been assessed as likely to ...
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
Locally made medicines
4 April 2022 - The Morrison Government is supporting new local jobs in Australia’s innovative medical sector and investing to secure ...
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 31 Mar 2022
COVID-19 vaccine weekly safety report (31 March 2022)
31 March 2022 - To 27 March 2022, the TGA has received 509 reports which have been assessed as likely to ...
Posted by Michael Wonder on 30 Mar 2022
Drug trials a ‘ticking time bomb’: ex-TGA agent
28 March 2022 - A former TGA official who led the regulator’s inspections program has warned that a lack of ...