Latest Us Regulatory News

Mesoblast has treated 350 patients in its pivotal Phase 3 trial for rexlemestrocel-L, targeting chronic low back pain linked to degenerative disc disease, setting the stage for top-line results in mid-2027.

Dateline Resources faces a US court injunction halting operations at its Colosseum Project, while ASX suspends and then reinstates trading over disclosure timing concerns.

AdAlta’s lead CAR-T therapy EW-001 continues to demonstrate encouraging survival and response rates in its mesothelioma study, with all patients alive at the latest follow-up and stronger outcomes at higher doses supporting plans for an Australian Phase 1 trial.

OD6 Metals has completed its acquisition of the Quinn Fluorspar Project, consolidating 100% ownership of 226 mining claims in Nevada and positioning itself as a potential key domestic fluorspar supplier for the US.

Control Bionics has achieved FDA registration for its NeuroStrip surface EMG platform, cementing its medical device status in the US and bolstering its appeal in clinical and research markets.

OncoSil Medical reported a 53% increase in unit sales and advanced key regulatory approvals, including FDA final review and TGA listing, positioning it for growth in pancreatic cancer treatment.

Aurora Energy Metals progresses the Aurora Uranium Project with a major drill program imminent under Eagle Nuclear Energy, while broadening its Western Australian footprint with new exploration licences at Mukinbudin.

Li-S Energy marked key commercial and regulatory milestones in Q2 2026, including ISO 9001:2015 certification for its lithium foil line, first commercial foil sale, and US air transport approvals for lithium-sulfur cells. The company also completed a major Battery Testing Centre expansion and began deep-ocean cell testing with MSubs.

Entropy Neurodynamics has reported breakthrough Phase 2 clinical results for its intravenous psilocin therapy in treatment-resistant Binge Eating Disorder, alongside strong Phase 2a data in Irritable Bowel Syndrome and a new US patent filing.

Vectus Biosystems has appointed Cardinal Health Regulatory Services as its US regulatory agent to manage FDA submissions for its lead fibrosis drug VB0004, marking a pivotal step towards clinical development in the US.

Orthocell Limited has posted record revenue for FY2026, driven by strong sales growth of Remplir™ and Striate+™ products in Australia, the US, and new international markets, supported by a robust $44.1 million cash position.

Noxopharm has taken a key regulatory step by requesting a pre-IND meeting with the US FDA for its autoimmune drug candidate SOF-SKN, aiming to smooth the path for clinical development and boost its commercial appeal.