Latest Regulatory Milestones News

Cambium Bio has secured FDA clearance to begin Phase 3 dosing for its lead ophthalmology product, Elate Ocular®, alongside key global partnerships and a $2.4 million capital injection from a major shareholder.

Arovella Therapeutics reported a 22% increase in half-year losses to $1.88 million while securing FDA acceptance of its IND application for lead asset ALA-101, paving the way for first-in-human trials.

Alcidion has secured regulatory approval for its AI-powered clinical tool in Australia and the UK, paving the way for commercial rollout in its largest markets. This milestone strengthens its position in healthcare technology and opens new sales avenues.

Australian Vanadium Limited has broadened its Optimised Feasibility Study to include high purity vanadium products aimed at aerospace, defence, and advanced manufacturing sectors, aligning with evolving critical minerals demand without delaying project timelines.

Cleo Diagnostics has chosen Bio-Techne’s next-generation Ella™ platform to enhance its ovarian cancer blood test, aiming for faster, more precise results and a streamlined path to FDA approval.

Bayan Mining has submitted its Plan of Operations to the U.S. Forest Service, marking a key regulatory milestone ahead of its maiden 3,000m diamond drilling program at Bayan Springs South in Nevada. The company also expanded its land holdings by 13%, securing critical extensions of mineralised zones.

3D Energi has announced two significant gas discoveries in the Otway Basin, validating its exploration models and advancing regulatory approvals. The company is now considering a follow-up well that could unlock further value in the region.

Tivan Limited has taken significant steps forward at its 100% owned Molyhil Tungsten Project, awarding major engineering contracts and preparing for a maiden drilling program aimed at expanding its resource base.

Bannerman Energy has secured a landmark $321.5 million strategic investment from CNNC Overseas Limited to jointly develop the Etango Uranium Project in Namibia, enabling debt-free construction and a market-priced offtake agreement with a Tier-1 nuclear utility.

Invex Therapeutics reports a net loss of $715,582 for H1 2026 while advancing its Exenatide program targeting neurological diseases, alongside notable board reshuffles.

Patrys Limited has appointed Dr Samantha South as its new CEO, aiming to leverage her biotech expertise to fast-track clinical development and commercialisation of its therapeutic antibody pipeline.

Tartana Minerals has made significant strides in expanding its silver exploration footprint with uncontested progress on EPM 27220, covering historic high-grade silver mines. The company also restates a robust Nightflower Exploration Target and plans extensive drilling in 2026.