Latest Us Regulatory News

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.

Argent BioPharma has struck a global licensing deal for its CannEpil® epilepsy therapy with Splash Beverage Group, securing US$5.5 million upfront through convertible debt forgiveness and retaining manufacturing and intellectual property rights alongside a 15% royalty on future sales.

Barramundi Limited’s May update reveals a 2.3% adjusted NAV decline, weighed down by CSL’s earnings downgrade and Brambles’ operational setbacks, despite positive contributions from Xero and Credit Corp.

OncoSil Medical has cleared a major regulatory hurdle as its Humanitarian Device Exemption application nears FDA approval, while its TRIPP-FFX trial shows promising results combining OncoSil with standard chemotherapy for pancreatic cancer.

Island Pharmaceuticals has kicked off GMP manufacturing of its antiviral Galidesivir to support late-stage Marburg virus studies under the FDA Animal Rule, marking a key step towards regulatory submission and biodefence readiness.

Pioneer Minerals has appointed Alaska Midnight Sun Drilling for its first reverse circulation drill campaign at the Springfield Tungsten, Gold and Gallium Project in Idaho, targeting high-grade multi-commodity mineralisation in Q3 2026.

Bayan Mining and US Critical Materials have signed a non-binding MoU to develop rare-earth processing technologies licensed from the Colorado School of Mines, targeting high-grade mineralisation at the Sheep Creek Project in Montana. The collaboration aims to support a US-based rare earth supply chain with potential strategic investment on the horizon.

Noxopharm is gearing up for a pivotal pre-IND meeting with the US FDA, enlisting global CRO Novotech to sharpen its regulatory approach for SOF-SKN, a drug targeting autoimmune skin diseases.