Latest Regulatory Strategy News

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Immuron Limited reports topline results from a Uniformed Services University trial of a third-party ETEC product that missed its primary endpoint, reaffirming commitment to its established Travelan dosing ahead of FDA discussions.
Ada Torres
Ada Torres
10 Dec 2025
InhaleRx Limited has secured $427,500 from an initial tranche of its $1 million capital raise, issuing 17.1 million shares to support its inhaled therapies targeting pain and mental health conditions.
Ada Torres
Ada Torres
9 Dec 2025
Nexsen Limited has appointed internationally acclaimed surgeon-scientist Professor Shekhar Kumta to its board, aiming to fast-track clinical validation and regulatory approval for its rapid diagnostic platforms ahead of a planned 2026 market entry.
Ada Torres
Ada Torres
3 Dec 2025
Pathkey.AI has teamed up with Armstrong Clinical to blend AI-driven trial predictions with expert clinical strategy, aiming to boost early-phase trial success and accelerate drug development in Australia and beyond.
Ada Torres
Ada Torres
12 Nov 2025
Anteris Technologies has secured FDA approval to commence its pivotal PARADIGM clinical trial, testing its innovative DurAVR Transcatheter Heart Valve against established devices in patients with severe aortic stenosis.
Ada Torres
Ada Torres
3 Nov 2025
Cleo Diagnostics has secured positive FDA feedback and nearly 1,600 biobank samples, accelerating its ovarian cancer blood test development ahead of a planned 2026 U.S. market entry.
Ada Torres
Ada Torres
31 Oct 2025
Neurizon Therapeutics has secured FDA clearance to resume clinical trials for its lead ALS drug candidate NUZ-001 and strengthened its balance sheet with a $5.2 million capital raise. The company is now poised to enter the pivotal HEALEY ALS Platform Trial, marking a significant step forward in its neurodegenerative disease program.
Ada Torres
Ada Torres
31 Oct 2025
Optiscan Imaging Ltd secured $17.75 million in a fully underwritten equity raise, fueling clinical studies and regulatory preparations for its innovative medical imaging devices. The company also reported progress in international trials and strengthened its cash position to nearly $20 million.
Ada Torres
Ada Torres
28 Oct 2025
Arovella Therapeutics has secured encouraging feedback from the US FDA on reagent testing for its CAR-iNKT cell therapy, setting the stage for an IND filing this quarter and clinical trials in early 2026.
Ada Torres
Ada Torres
28 Oct 2025
Artrya Limited has successfully navigated a key FDA Q-Submission meeting, receiving clear guidance on the regulatory pathway for its Salix Coronary Flow module, with a 510(k) submission planned by year-end.
Ada Torres
Ada Torres
10 Oct 2025
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.
Ada Torres
Ada Torres
8 Oct 2025
Cleo Diagnostics has received encouraging feedback from the U.S. FDA on its ovarian cancer pre-surgical triage test, reinforcing its clinical trial design and regulatory strategy ahead of a critical 510(k) submission.
Ada Torres
Ada Torres
15 Sept 2025