Latest Regulatory Approval News

Wide Open Agriculture has developed a novel lupin protein milk formulation that overcomes longstanding technological hurdles, lodging a patent to protect its innovation and gearing up for global commercialisation.

Algorae Pharmaceuticals has signed a binding term sheet with India’s Cadila Pharmaceuticals to introduce two generic medicines targeting cardiovascular and metabolic disorders in Australia and New Zealand.

Race Oncology showcased compelling preclinical data at ESMO 2025 revealing that their drug RC220, combined with doxorubicin, not only shields the heart from toxicity but also boosts anticancer effects, supporting ongoing clinical trials.

Imricor Medical Systems has completed the world’s first Pulsed Field Ablation procedure under real-time MRI guidance, marking a breakthrough in cardiac ablation technology. This pre-clinical success validates their Vision-MR platform’s adaptability and sets the stage for safer, radiation-free heart treatments.

Orthocell has boosted its investment in Marine Biomedical to secure exclusive global distribution rights for PearlBone™, an innovative bone substitute nearing FDA approval, enhancing its regenerative medicine portfolio.

Prodigy Gold has reported a milestone with over one million ounces of gold in its resource inventory, alongside significant exploration progress and a successful $7.13 million capital raise to fund ongoing development.

Zip Co Limited has reported a near doubling in cash earnings for Q1 FY26, driven by robust transaction growth and improved operating leverage, particularly in the US market. The company also doubled its share buy-back program and raised its US transaction volume growth guidance.

Ballard Mining’s infill drilling at the Baldock deposit continues to reveal strong high-grade gold intersections, underpinning plans for a maiden ore reserve by mid-2026. The program is 74% complete, boosting confidence in resource conversion and future mine life.

Brazilian Critical Minerals has achieved a major environmental milestone at its Ema Rare Earth Elements project, successfully restoring clay chemistry post in-situ recovery trials. This breakthrough supports regulatory approvals and moves the project closer to production.

Botanix Pharmaceuticals reports a strong start to FY26 with a 50% surge in Sofdra prescriptions and a 65% rise in net revenue, underpinned by a larger sales team and operational efficiencies.

Bayan Mining and Minerals has made significant strides at its Desert Star Projects in California, including key technical appointments, regulatory approvals, and preparations for maiden drilling. Positioned near major rare earth and gold mines, the projects reaffirm their potential to contribute to North America's critical minerals supply chain.

Immutep’s novel immunotherapy combination with KEYTRUDA and chemotherapy shows promising response rates in first line non-small cell lung cancer, especially in patients with low or no PD-L1 expression.