Snapshot from May 30, 2026 at 07:00 UTC. For live data and tracking: View Live
Events / Business / Norgine PEDMARQSI TGA Australia Approval
Business regulatory approval

Norgine PEDMARQSI TGA Australia Approval

Analysis based on 6 articles · First reported May 05, 2026 · Last updated May 05, 2026

Sentiment
60
Attention
2
Articles
6
Market Impact
Direct
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Market Impact

The TGA registration of PEDMARQSI in Australia is a positive development for Norgine, expanding its market presence and potential revenue from this specialized medicine. This approval provides a new treatment option for paediatric cancer patients in Australia, addressing an unmet medical need.

pharmaceuticals biotechnology
Event Summary

Norgine announced that its drug PEDMARQSI (sodium thiosulfate anhydrous) has been registered by the Australia — Therapeutic Goods Administration in Australia. This registration allows for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy in children aged 1 month to less than 18 years with localised, non-metastatic, solid tumours. This marks the first and only treatment of its kind registered in Australia. The approval is based on data from two Phase 3 clinical trials, SIOPEL 6 and COG ACCL0431. This Australian approval follows previous marketing authorisations in other territories, including a Paediatric Use Marketing Authorisation from the European Union — European Medicines Agency in May 2023, a national marketing authorisation in the United Kingdom, and Switzerland — Swissmedic approval in March 2026. Gus Rudolph and Dr. David Gillen of Norgine highlighted the significance of this milestone for children, families, and healthcare professionals in Australia.

Key Actions
100 Australia — Therapeutic Goods Administration registered PEDMARQSI Norgine
40 European Union — European Medicines Agency granted marketing authorisation Norgine
30 United Kingdom granted marketing authorisation Norgine
30 Switzerland — Swissmedic approved PEDMARQSI Norgine
Entities Involved
priv
Norgine
Norgine received TGA registration for PEDMARQSI in Australia, expanding its market reach for this specialized medicine.
Importance 100 Sentiment 70
govactor
Australia — Therapeutic Goods Administration
The Australia — Therapeutic Goods Administration granted registration for PEDMARQSI, making it available in Australia.
Importance 80 Sentiment 0
cnt
Australia
Australia is the country where PEDMARQSI received TGA registration, providing a new treatment option for its paediatric patients.
Importance 70 Sentiment 0
govactor
European Union — European Medicines Agency
The European Union — European Medicines Agency previously granted Paediatric Use Marketing Authorisation for PEDMARQSI in May 2023.
Importance 30 Sentiment 0
cnt
United Kingdom
The United Kingdom previously granted national marketing authorisation for PEDMARQSI.
Importance 20 Sentiment 0
govactor
Switzerland — Swissmedic
Switzerland — Swissmedic approved PEDMARQSI in March 2026.
Importance 20 Sentiment 0
per
Gus Rudolph
Gus Rudolph, General Manager for Norgine in Australia, commented on the significance of the TGA registration.
Importance 10 Sentiment 0
per
David Gillen
Dr. David Gillen, Chief Medical Officer at Norgine, highlighted the clinical importance of the approved preventive option.
Importance 10 Sentiment 0
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