Countries Australia
Anivive Wins Full U.S. FDA Approval for Laverdia, First At-Home Oral Treatment for Canine Lymphoma
Anivive converts Laverdia-CA1 to full FDA approval First FDA-approved product to validate Anivive's AI-enabled development model &md...
June 30, 2026 | News
4DMedical Secures Australian TGA Approval for CT:VQ™, Advancing Non-Contrast Functional Lung Imaging
4DMedical Limited (ASX: 4DX), the global leader in advanced respiratory imaging, announced that CT:VQ™ technology has Therapeutic Goods Adminis...
June 30, 2026 | News
CStone Partners with Arrotex to Commercialize Sugemalimab in Australia and New Zealand
Arrotex, the pharmaceutical commercialization platform of DBG, Australia's leading diversified healthcare group, will be responsible for the registration...
June 29, 2026 | News
Racura Oncology Doses First Patient in Phase 1 HARNESS-1 Trial of RC220 for EGFR-Mutant Lung Cancer
Racura Oncology has dosed the first patient in the HARNESS-1 Phase 1a/b trial of RC220 in combination with osimertinib for EGFR-mutant non-small cell lung ...
June 29, 2026 | News
The Frontier That Won’t Quite Arrive
Ask the region’s clinical-operations leaders whether decentralised and hybrid trials are the future, and the answer is almost unanimous. Surveys keep...
June 26, 2026 | Analysis
Avance Clinical Expands APAC And China Operations To Accelerate Global Biotech Trials
Avance Clinical, the Australian-headquartered global Contract Research Organization (CRO) for biotechs, announced a significant expansion of its Asia Pacif...
June 22, 2026 | News
HaemaLogiX Secures Ethics Approval For Phase 2b KappaMab Clinical Trial In Relapsed Multiple Myeloma
Ethics approval received from the Alfred Hospital Human Research Ethics Committee (Bayside Health) for Phase 2b KappaMab™ clinical trial “HLX...
June 22, 2026 | News
Dimerix Signs Up to AU$481 Million Licensing Deal with Everest Medicines to Advance Phase 3 Kidney Disease Therapy Across Asia
Dimerix Limited (ASX: DXB), a biopharmaceutical company developing innovative therapies for rare inflammatory diseases, has entered into an exclusive licen...
June 17, 2026 | News
CGBIO Expands Global NOVOSIS Partnership With DePuy Synthes Into North America And Australia
DePuy Synthes secures exclusive commercialization rights in North America and Australia; the two companies to jointly advance global clinical development...
May 28, 2026 | News
Caliway Advances Global Phase 3 Programme For CBL 514 Following U.S. FDA IND Clearance
Asia-Pacific Phase 2 Study CBL-0206 Also Approved by Australia HREC and Taiwan TFDA, Accelerating Global Dual-Track Strategy ...
May 26, 2026 | News
Registrar Corp And U.S. Commercial Service Strengthen Support For Australian Exporters Entering U.S. Market
Registrar Corp, the global leader in U.S. Food and Drug Administration (FDA) regulatory compliance services, partnered with the U.S. Commercial Servic...
May 26, 2026 | Regulatory
Scribe Therapeutics Gains Australian Clearance To Begin First Human Trial Of STX 1150 For Hypercholesterolemia
Scribe Therapeutics, Inc. (Scribe), a clinical-stage biotechnology company engineering purpose-built in vivo CRISPR technologies designed to exte...
May 26, 2026 | News
HaemaLogiX Opens Phase 1 KOALA Trial Of KMCAR T Cell Therapy For Relapsed Multiple Myeloma
Phase 1 KOALA clinical trial evaluating KMCAR™ T-cell therapy in relapsed/refractory kappa-restricted multiple myeloma now open for patient enrolme...
May 21, 2026 | News
Racura Oncology Receives Positive Safety Review Committee Recommendation To Advance CPACS Trial In Advanced Solid Tumours
Safety Review Committee (SRC) gives Racura Oncology a recommendation to continue the Cardioprotection and Anticancer Synergy (CPACS) study in advanced soli...
May 18, 2026 | News
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