Latest Regulatory Approval News

Radiopharm Theranostics has reached the halfway mark in enrolling patients for its Phase 2b trial of RAD101, a novel imaging agent targeting brain metastases. Early data suggest RAD101 may outperform MRI in distinguishing tumor recurrence from radiation damage.

Taiton Resources has received regulatory approval to commence drilling at the Yogi prospect within its Highway Project, targeting promising mineralisation in South Australia’s Gawler Craton. The maiden drill program aims to test a significant gravity anomaly indicative of IOCG or rare earth elements.

Prominence Energy Ltd has made significant technical progress at its Gawler Hydrogen Project, confirming high-grade natural hydrogen potential and preparing for a major geochemical survey in early 2026. The company also strengthens its global position by joining a prestigious hydrogen delegation to Korea.

Robex Resources reported a $16.5 million net loss in Q3 2025 and completed full drawdown of its $130 million project financing facility, progressing its Kiniéro gold project with a planned first gold pour in December. The company also announced a merger agreement with Predictive Discovery Limited, signaling strategic growth.

Horizon Minerals has agreed to sell its Lake Johnston Project to Forrestania Resources for $35 million, aiming to refocus on advancing its Black Swan gold operations.

Horizon Minerals has agreed to sell its Lake Johnston Project for $35 million to Forrestania Resources, aiming to bolster funding for its flagship Black Swan gold project. The deal combines cash and shares, positioning Horizon for growth and operational advancement.

Tamboran Resources has sanctioned its Shenandoah South Pilot Project, completed a record drilling campaign, and is progressing infrastructure to deliver gas to the Northern Territory by mid-2026. The company also announced a planned acquisition of Falcon Oil & Gas and raised $56 million in a public offering.

PYC Therapeutics reports sustained vision improvements in patients with Retinitis Pigmentosa type 11 treated with VP-001, showing promising safety and efficacy up to 18 months. The company plans to engage the FDA in early 2026 to finalize pivotal trial design.

Bio-Gene Technology’s natural insecticide Qcide® has earned organic listing status from the US Organic Materials Review Institute, marking a pivotal step for its entry into the organic pest control market.

Synlait Milk Limited has temporarily expanded its banking facilities by NZ$50 million to manage ongoing cost impacts from earlier manufacturing challenges, while preparing to reduce debt through a major asset sale.

Island Pharmaceuticals will host a webinar to discuss the FDA's feedback on the clinical development and regulatory approval of its antiviral drug Galidesivir, including key considerations under the FDA's Animal Rule and Priority Review Voucher eligibility.

The Australian Competition and Consumer Commission has given the green light to Southern Cross Media’s proposed acquisition of Seven West Media, marking a significant regulatory milestone in the evolving Australian media landscape.