Latest Us Regulatory Approval News

Venari Minerals says it knows of no undisclosed information behind a sharp rise in its share price and trading volume. The company points instead to ongoing Red Mountain drilling and a proposed exploration program still awaiting US regulatory approval.

Emyria has secured a limited in-person speaking position at a US FDA hearing examining how psychedelic medicines could be delivered safely and at scale. The appearance gives the ASX-listed company a regulatory platform, but does not represent FDA approval, funding or a commercial agreement.

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.

Imricor Medical Systems has secured Virginia Commonwealth University Health as the third US site for its VISABL-AFL clinical trial, advancing its FDA approval pathway for MRI-guided cardiac ablation technology.

The Australian Treasurer has approved Hanwha Corporation’s increase of its direct equity stake in Austal Limited from 9.9% to 19.9%, setting the stage for potential strategic partnerships as Austal rides a wave of record revenues and defence contracts.

Island Pharmaceuticals has submitted a detailed briefing to the FDA aiming to accelerate approval of its antiviral Galidesivir for Marburg virus under the Animal Rule, with feedback expected by November.

ReNerve Limited reported a robust 53% increase in annual revenue, driven by strategic partnerships and new regulatory approvals that broaden its global footprint in nerve repair.

PainChek has advanced its US regulatory approval process with a positive FDA meeting, setting the stage for a potential market debut of its pain assessment app in late 2025.