Latest Regulatory Approval News

Arovella Therapeutics has secured a crucial regulatory nod from the U.S. FDA, allowing its lead CAR-iNKT cell therapy, ALA-101, to enter first-in-human clinical trials targeting blood cancers.

Ragusa Minerals has executed a binding agreement to acquire a majority interest in the Purple Pansy manganese-gold project in Arizona, expanding its landholding and raising $600,000 to fund exploration.

PainChek has secured FDA-regulated medical device status, enabling US Remote Therapeutic Monitoring reimbursement and opening a major US growth avenue. The company targets musculoskeletal pain management in non-verbal dementia patients, a largely underserved market.

Nova Eye Medical has reported a record US$6.1 million in global sales for the December 2025 quarter, marking a 38% year-on-year increase and strong momentum across key markets. The company’s innovative iTrack™ technology continues to drive growth, supported by expanded manufacturing capacity and advancing clinical programs.

Cleo Diagnostics has broadened its U.S. market opportunity to around 2 million women annually and is on track to complete its pivotal clinical trial early this year, supported by a $5 million capital raise and regulatory progress.

Great Divide Mining has resolved a key joint venture dispute to move towards 100% ownership of the Challenger Gold Mine, while progressing promising exploration results and joint ventures across its Queensland and New South Wales projects.

Bayan Mining and Minerals Limited has secured exclusive rights to advanced rare earth processing technologies and made significant progress on its US exploration projects, setting the stage for maiden drilling in 2026.

Strike Resources has signed a non-binding Memorandum of Understanding with Naviera Petral to develop port infrastructure in Peru, supporting the export of its high-grade Apurimac iron ore. This strategic move aims to reduce logistics costs and pave the way for a return to production.

Torque Metals is advancing its Paris Gold Camp project in Western Australia, moving from exploration to development readiness with a 250,000-ounce gold resource and an aggressive drilling program.

Mineral Resources Limited has upgraded its lithium production guidance and reported record iron ore shipments in Q2 FY26, alongside a significant reduction in net debt and a strategic joint venture with POSCO Holdings.

BPH Energy’s December quarter report reveals significant progress in its investee projects amid ongoing legal challenges and strategic capital management. The company balances judicial reviews, regulatory milestones, and funding plans across energy and medical technology sectors.

Orpheus Uranium Limited made significant strides in 2025 with critical land-access agreements and regulatory approvals across its uranium projects, positioning the company for advanced exploration in 2026. The acquisition of the Oobagooma Project further diversifies its portfolio in Western Australia.