Latest Clinical Trial Approvals News

AdAlta has engaged specialist advisors to streamline US FDA regulatory processes for its CAR-T therapy BZDS1901, which has shown rare complete tumour clearance in advanced mesothelioma patients.

Biome Australia has taken a significant step in its innovation journey by filing a patent for its next generation probiotic strain BMB18, with a clinical trial set to begin in Q4 FY26 in partnership with La Trobe University.

Arovella Therapeutics has secured TGA confirmation to advance its Phase 1 trial of ALA-101 in Australia via the efficient Clinical Trial Notification pathway, following FDA clearance in the US.

InhaleRx has secured swift Human Research Ethics Committee approval for its redesigned IRX-211 Phase 2 trial, expanding participant numbers and potentially bypassing Phase 3 to speed market entry.

Cardiex reports strong early sales momentum for its CONNEQT Pulse device with approximately 3,000 units sold or contracted since its mid-January launch, supported by innovative app features and operational efficiencies. Despite regulatory delays in the US pharma sector and tariff challenges, the company is positioned for scalable growth and category leadership in preventative cardiovascular care.

TrivarX has launched a pivotal mental health clinical trial in partnership with the US Department of Veterans Affairs, leveraging its innovative ECG-based technology to screen for major depressive episodes. The company also secured $2.25 million in funding, positioning it for regulatory milestones ahead.

Optiscan Imaging Ltd reported a productive December quarter, marked by key product developments, strategic partnerships, and a stronger cash position, setting the stage for growth in medical and veterinary imaging markets.