Latest Regulatory Milestones News

Imricor Medical Systems expands its US market reach with FDA 510(k) clearances for pediatric use of its NorthStar system and Vision-MR Diagnostic Catheter, enabling radiation-free cardiac catheterisations for children.

Native Mineral Resources (ASX:NMR) has cleared a key regulatory hurdle by submitting a Progressive Rehabilitation and Closure Plan for its Far Fanning Gold Project, while maintaining steady gold production at its Blackjack Gold Mine.

Capricorn Metals has gained crucial federal environmental approval for expanding its Mount Gibson Gold Project, clearing a key hurdle toward development commencement in late 2026.

GoldArc Resources has completed the first phase of a 34,000m grade control drilling program at Mt Stirling, delivering consistent broad mineralisation and higher-grade zones that underpin updated mine models ahead of regulatory approval.

Clarity Pharmaceuticals will present compelling data at EANM 2026 demonstrating its 64Cu-SAR-bisPSMA imaging agent’s superior detection of prostate cancer recurrence and promising therapeutic results from 67Cu-SAR-bisPSMA in advanced disease.

Audalia Resources (ASX: ACP) is seeking to raise $450,000 through a placement of 15 million shares at 3 cents each, aiming to fund the Medcalf project’s progression and shore up working capital.

Po Valley Energy has lodged a crucial Environmental Impact Assessment for a four-well gas drilling program at its Selva Malvezzi concession in Northern Italy, aiming to boost production and support regional energy needs.

Novatti has cashed in $1.2 million by selling part of its AUDC shares at $0.80 each, marking its first divestment since incubating the stablecoin issuer in 2022, yet keeps a substantial holding to benefit from future growth.

Echo IQ has locked in a binding Heads of Agreement with Pro Medicus for a strategic A$20 million investment and a US commercial partnership to accelerate adoption of its AI-powered cardiac diagnostic platform.

The a2 Milk Company has announced a $300 million fully franked special dividend following regulatory clearance in China to rebrand infant formula products under its a2 label.

American West Metals is finalising its Pre-Feasibility Study for the Storm Copper Project in Nunavut, advancing permitting and exploration along a 110km copper belt, backed by secured development funding.

AFT Pharmaceuticals surged 22% to NZ$254.7 million revenue in FY26, surpassing profit guidance and securing FDA approval to advance a pivotal injectable iron Phase III trial targeting a $7.4 billion market. The company is poised for further global expansion and product launches in FY27.