Latest Us Regulatory News

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.

AdAlta has secured A$2.5 million in a strategic placement to push its lead CAR-T therapy BZDS1901 through critical US FDA regulatory steps and establish Australian manufacturing, building on promising clinical responses in advanced mesothelioma.

LTR Pharma highlights SPONTAN's 5x faster absorption and validated safety, backed by over 1,000 Australian prescriptions and strategic partnerships as it targets FDA approval and US market entry.

Volt Resources has secured a major extension and volume increase to its Bunyu graphite offtake agreement while progressing high purity graphite production and downstream refinery development in the US.

IDT Australia is poised for its strongest FY26 finish since its transformation began, forecasting a dramatic narrowing of EBITDA losses and revenue growth driven by strategic partnerships and operational upgrades.

PYC Therapeutics has gained Orphan Drug Designation from the European Medicines Agency for its VP-001 candidate targeting Retinitis Pigmentosa type 11, enhancing its regulatory and commercial pathway in Europe.

Resolution Minerals has raised A$20 million in a strongly supported institutional placement to accelerate exploration and development at its US Horse Heaven Project, while preparing for a NASDAQ listing to boost its US market presence.