Latest Regulatory Approvals News

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Manuka Resources’ subsidiary Trans-Tasman Resources has entered a pivotal phase as an expert panel starts assessing its Fast Track application for seabed mining off New Zealand’s coast, aiming to unlock significant economic and mineral export potential.
Maxwell Dee
Maxwell Dee
21 Aug 2025
Prominence Energy Limited has secured a pivotal natural hydrogen exploration license in South Australia, marking a major step forward for its Gawler Hydrogen Project and positioning it among the state’s leading clean energy explorers.
Maxwell Dee
Maxwell Dee
21 Aug 2025
Reef Casino Trust faces a new takeover challenge as Morris Group submits a conditional $191.7 million cash offer, competing with the board-backed Iris proposal. The trust’s Independent Board Committee urges unitholders to hold off while assessing the competing bids.
Eva Park
Eva Park
21 Aug 2025
Peet Limited reported a robust FY25 with a 60% surge in net profit after tax and declared a higher fully franked dividend, underpinned by strong sales and improved capital management. The company is also undertaking a strategic business review while navigating leadership transitions.
Eva Park
Eva Park
21 Aug 2025
Tryptamine Therapeutics has secured an exclusive agreement with leading neuroscientists to develop a novel EEG-based brain entropy biomarker aimed at enhancing precision psychiatry for its psychedelic drug TRP-8803.
Ada Torres
Ada Torres
21 Aug 2025
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.
Victor Sage
Victor Sage
21 Aug 2025
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.
Ada Torres
Ada Torres
21 Aug 2025
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.
Ada Torres
Ada Torres
21 Aug 2025
Medical Developments International reports a strong FY25 with significant margin gains and strategic progress, setting the stage for accelerated Penthrox expansion in FY26.
Ada Torres
Ada Torres
21 Aug 2025
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.
Victor Sage
Victor Sage
21 Aug 2025
Artrya Limited has secured FDA 510(k) clearance for its Salix Coronary Plaque module, enabling near real-time detection of high-risk coronary artery plaque and opening a lucrative U.S. market opportunity with a $950 reimbursement per scan.
Ada Torres
Ada Torres
21 Aug 2025
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.
Ada Torres
Ada Torres
21 Aug 2025