Blog
RSS FeedPosted 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 22 Jul 2022
Medicines industry working to minimise medicine supply shortages
22 July 2022 - Medicines Australia and the Generic and Biosimilars Medicines Association are deeply concerned about medicine shortages that ...
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 28 Jun 2022
Fees and charges: summary from 1 July 2022
27 June 2022 - The TGA has updated its summary of fees and charges effective 1 July 2022. ...
Posted by Michael Wonder on 15 Jun 2022
TGA approves Vyxeos
15 June 2022 - This marks the first TGA approval for Jazz Pharmaceuticals. ...
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 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
Prescription medicines: applications under evaluation (May 2022)
26 May 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...
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 16 May 2022
Pfizer settles two lawsuits, starts another over etanercept biosimilar in Australia
17 May 2022 - After agreeing to settle with Amgen over its oncology biosimilars, Pfizer issued a new patent lawsuit ...
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 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 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. ...