Blog
RSS FeedPosted by Michael Wonder on 19 Jan 2025
Junshi Biosciences announces toripalimab’s approval in Australia
17 January 2025 - Shanghai Junshi Biosciences announced that toripalimab, the anti-PD-1 monoclonal antibody self-developed by the company, has obtained the ...
Posted by Michael Wonder on 16 Apr 2024
Norgine submits marketing authorisation application via Project Orbis for eflornithine (difluoromethylornithine) in high-risk neuroblastoma
15 April 2024 - Norgine today announced its first marketing authorisation application submissions on 10 April 2024, seeking approval for eflornithine ...
Posted by Michael Wonder on 03 Dec 2023
Junshi Biosciences announces new chemical entity application for toripalimab accepted by Australia’s TGA
1 December 2023 - Shanghai Junshi Biosciences announced that the TGA has accepted the new chemical entity application for toripalimab in ...
Posted by Michael Wonder on 25 Jul 2023
Peter Mac increases manufacturing centre for gene therapy bringing new hope to cancer patients
25 July 2023 - Australia’s first biomedical manufacturing facility has opened in Melbourne and will boost lifesaving therapy for cancer patients ...
Posted by Michael Wonder on 29 Jun 2023
Lymphoma therapy now approved for Australian patients with diffuse large B-cell lymphoma
28 June 2023 - Recent five-year follow-up data from Phase 2 L-MIND investigation showed patients treated with Minjuvi had prolonged, ...
Posted by Michael Wonder on 06 Jun 2023
‘Future of cancer treatment’ has just been approved
6 June 2023 - Australian scientists pioneering a new type of therapy, which re-engineers a patient’s own T-cells, could result in ...
Posted by Michael Wonder on 24 Aug 2022
Prescription medicines: applications under evaluation
24 August 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...
Posted by Michael Wonder on 24 Aug 2022
Roche withdraws application for Tecentriq
25 August 2022 - Publication of AusPAR reveals the withdrawal of the application in July 2021. ...
Posted by Michael Wonder on 01 Aug 2022
TGA approves new medicine for NSCLC patients with an EGFR exon 20 mutation
1 August 2020 - First medicine approved by the TGA for this mutation. ...
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 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 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 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 ...