Latest Regulatory Approvals News

Downer EDI Limited reported a robust FY25 with a 33% rise in underlying NPATA and announced a $230 million share buy-back, underscoring confidence in its transformation and growth outlook. The company’s disciplined portfolio simplification and operational improvements set the stage for steady FY26 performance despite short-term market softness.

Medical Developments International has reported a remarkable turnaround in FY25, posting a net profit after tax and securing paediatric approval for its flagship product Penthrox in Europe.

Medical Developments International Ltd reported an 18% increase in revenue to $39.1 million for FY25, returning to profitability with a net profit after tax of $0.1 million. The company advanced its Penthrox market expansion through regulatory approvals and new partnerships.

Medical Developments International reports a strong FY25 with significant margin gains and strategic progress, setting the stage for accelerated Penthrox expansion in FY26.

Downer EDI reports a robust FY25 with statutory profit soaring 82% and announces a $230 million share buy-back, signaling confidence in its ongoing transformation.

Telix Pharmaceuticals reported a robust 63% year-over-year revenue increase in H1 2025, driven by strong sales of its precision medicine products and strategic acquisitions. The company is advancing multiple late-stage clinical trials and expanding its global manufacturing footprint.

Telix Pharmaceuticals reported a robust 63% revenue increase in H1 2025, driven by commercial expansion and strategic investments in R&D and manufacturing. The company confirms full-year guidance while advancing key clinical trials and product launches.

Telix Pharmaceuticals reported a robust 63% increase in revenue to $390.4 million for the first half of 2025, driven by strong Illuccix sales and the acquisition of RLS Radiopharmacies. Despite this growth, the company recorded a net loss of $2.3 million, reflecting increased investments and finance costs.

Janus Electric has inked a $5 million Memorandum of Understanding with EVUNI to distribute its electric drivetrain technology across Africa, marking a bold step in its international growth strategy.

Octava Minerals reports impressive initial bioleaching recoveries of critical rare earth elements and lithium from its Byro Project, highlighting a promising, low-cost extraction pathway.

Artrya Limited reported a 17.2% increase in net loss to $16.4 million for FY25, while achieving FDA clearance and launching its AI-driven Salix platform in the U.S. market. The company also secured key commercial partnerships in Australia and raised $20 million in equity funding.

Astron Corporation Limited is set to redomicile from Hong Kong to Australia through a scheme of arrangement, creating a new Australian parent company, Aus NewCo. This move aims to align the corporate structure with its Australian assets and simplify shareholder voting.