Latest Us Regulatory News

PainChek Ltd has secured FDA De Novo clearance for its Adult App, marking a pivotal entry into the US long-term care market and setting the stage for global expansion including its Infant App.

Prescient Therapeutics has achieved a key regulatory milestone with the European Medicines Agency granting Orphan Drug Designation for its PTX-100 therapy targeting Cutaneous T-cell Lymphomas, enhancing its commercial and clinical prospects in Europe.

Mandrake Resources has signed a term sheet with DISA Technologies to explore recovering uranium and critical minerals from abandoned mine waste in Utah, leveraging a unique US regulatory license and strong government backing.

ikeGPS has reported a robust first half of FY26 with subscription revenue soaring 47%, a successful A$24 million capital raise, and inclusion in the ASX All Ordinaries Index, underscoring its expanding footprint in the US grid modernization market.

MedAdvisor Solutions reported a steep 52.8% revenue decline in Q1 FY26, impacted by US regulatory pressures and vaccine program delays, while embarking on a strategic transformation to restore growth.

Aurora Energy Metals reports strong metallurgical results and progress toward Eagle Energy Metals’ Nasdaq listing, advancing the Aurora Uranium Project’s development.

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.