Latest Regulatory Progress News

Echo IQ Limited has advanced its EchoSolv heart failure solution towards FDA submission, driven by a landmark clinical validation study and a sharp rise in US platform adoption. Strategic partnerships and international expansion efforts underscore the company’s growing footprint in cardiology AI.

Cobalt Blue Holdings advances its Kwinana Cobalt Refinery with a critical Works Approval and secures letters of intent covering 70% of initial production, while its Broken Hill Cobalt Project gains a three-year Major Project Status extension.

Bioxyne Limited has reported a record-breaking first quarter for FY26, with revenues soaring 210% year-on-year, driven by strong demand in cannabis products and strategic European market advances.

Magnetite Mines has made significant strides in developing its Razorback Iron Ore Project, securing $3.86 million in new funding and uncovering promising rare earth mineralisation at Ironback Hill. The company continues to navigate strategic partnerships and regulatory approvals to advance its long-life magnetite project.

OncoSil Medical reports a remarkable 917% increase in quarterly cash receipts alongside promising clinical trial results and key European market entries, signaling robust momentum in its pancreatic cancer treatment rollout.

Arovella Therapeutics reported solid progress in Q1 FY26, moving closer to initiating its first-in-human trial for ALA-101 while securing key patents and maintaining a strong cash position.

NeuroScientific Biopharmaceuticals has secured regulatory approval for initial patient treatments under its Special Access Program for StemSmart™ in Crohn’s disease, alongside key executive appointments and a manufacturing partnership to support upcoming clinical trials.

Island Pharmaceuticals has completed its acquisition of the broad-spectrum antiviral Galidesivir and is progressing regulatory discussions with the FDA to fast-track approval using the Animal Rule, backed by compelling preclinical data.

Caravel Minerals has appointed Primero Group as its preferred EPCM firm and secured a $15 million loan to fund its Definitive Feasibility Study, marking significant progress toward a Final Investment Decision for the Caravel Copper Project.

CurveBeam AI reports a 33% rise in device purchase orders and secures a $6.5 million placement alongside a landmark China distribution partnership. The company advances FDA regulatory milestones and establishes a vendor financing facility to boost sales.

Ampol Limited reported a robust third quarter in 2025 with refinery margins hitting a notable high, offsetting volume declines and setting the stage for strategic growth.

Little Green Pharma reported a robust September quarter with revenue exceeding $10 million, driven by growth across all product lines and strong European market performance. The company is poised to benefit from upcoming regulatory reforms and operational efficiencies.