Latest Regulatory Pathways News

Echo IQ has initiated a pivotal clinical validation study with the Mayo Clinic Platform to test its EchoSolv HF software, marking the final step before its planned FDA submission in late 2025.

Actinogen Medical has enrolled its 100th participant in the XanaMIA phase 2b/3 Alzheimer’s trial, setting the stage for a critical interim analysis in January 2026 and final results by year-end.

LTR Pharma has successfully completed the extractables study for its intranasal erectile dysfunction spray SPONTAN, confirming safety compliance and initiating the next phase of leachables testing to support FDA approval.

BlinkLab has secured US Institutional Review Board approval to proceed with the main phase of its FDA 510(k) trial for an AI-powered autism diagnostic tool, marking a key step toward regulatory clearance.

Paradigm Biopharmaceuticals has acquired Proteobioactives, securing global rights to an oral combination therapy targeting early-stage osteoarthritis in humans and animals, complementing its injectable PPS phase 3 program.

Cleo Diagnostics has gained approval to access the prestigious PLCO biobank, a move set to strengthen its FDA submission and accelerate development of its ovarian cancer diagnostic tests.

Optiscan Imaging Ltd has entered a five-year exclusive collaboration with Long Grove Pharmaceuticals to jointly develop new clinical applications for the fluorescein drug AK-FLOUR®, supporting US clinical trials and FDA regulatory submissions for Optiscan’s InVue® surgical device.

Australian Silica Quartz Group's flagship Quartz Hill MGSi Project faces a setback after Quinbrook Infrastructure Partners terminates their development and offtake agreement. ASQ pivots to explore other high-grade quartz targets in Queensland.

NeuroScientific Biopharmaceuticals reveals compelling clinical evidence supporting its StemSmart MSC therapy for severe steroid-refractory graft versus host disease, advancing its strategic acquisition plans.

Nyrada’s Phase I clinical trial for its novel drug Xolatryp has cleared safety reviews through four cohorts and will now test higher doses and longer infusions in an expanded trial design.

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.

AdAlta Limited has successfully placed the remaining shortfall in its renounceable rights issue, raising a total of $1.3 million to advance its cellular immunotherapy pipeline. The company also addressed an administrative breach involving director share allocations, ensuring compliance with ASX rules.