Latest Us Regulatory News

Dimerix’s latest PARASOL collaboration analysis reinforces proteinuria as a pivotal endpoint in their Phase 3 FSGS trial, setting the stage for FDA discussions on accelerated approval pathways.

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.

Helios Energy has pinpointed a high-potential unconventional sweet spot alongside multiple conventional oil and gas targets within its Presidio Project, setting the stage for near-term drilling and potential value re-rating.

Actinogen Medical reports steady progress in its Alzheimer’s and depression drug trials, backed by strong funding and strategic commercial planning. Key interim data from the pivotal XanaMIA trial is expected early next year.

Sonic Healthcare reported solid FY2025 results with revenue up 7.6% and a steady profit increase, while declaring a 63-cent final dividend. The company’s recent German acquisition and ongoing synergy efforts set the stage for robust earnings growth in FY2026.

4DMedical has landed a $10 million strategic investment from Pro Medicus, aimed at accelerating its commercial growth and advancing its CT – VQ™ technology towards FDA clearance in the US.

Global Uranium and Enrichment Limited has completed a transformative acquisition of the Pine Ridge Uranium Project in Wyoming, initiating a large-scale drilling program that positions the company as a key domestic uranium developer in the US.

Neurotech International reports encouraging Phase I human pharmacokinetic results for its pediatric cannabinoid drug NTI164, alongside published clinical trial data in Rett Syndrome and key regulatory progress in the US and Australia.

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.

Imricor Medical Systems has secured key European regulatory approvals for its second-generation NorthStar system and initiated its commercial launch, while US FDA submissions progress amid some delays.

Bubs Australia has submitted critical clinical trial data to the US FDA, marking a pivotal step toward permanent approval for its infant formulas in the US market.

Hanwha Group claims US approval to fully own Austal, but independent checks suggest a narrower green light. Australian regulators still hold the final say on foreign ownership.