Latest Regulatory Pathways News

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.

Dimerix has reached a key milestone by dosing 200 adult patients in its Phase 3 ACTION3 trial for FSGS, progressing steadily toward full recruitment expected in late 2025.

Argenica Therapeutics faces a clinical hold from the US FDA on its stroke drug trial application, though its Australian Phase 2 study remains unaffected and on track.

Optiscan Imaging Ltd has launched InSpecta™, a cutting-edge microscopic imaging device tailored for veterinary medicine, marking its strategic entry into a booming $12 billion US market. The device promises to revolutionize diagnostics and treatment for companion animals with real-time, non-invasive imaging.

Neurotech International has reported positive human pharmacokinetic results for NTI164, a cannabinoid formulation designed for paediatric neurological disorders, confirming rapid absorption and a non-intoxicating profile.

EVE Health Group has initiated stability testing for its novel oral treatments targeting erectile dysfunction and dysmenorrhea, marking a crucial step toward regulatory approval in Australia. The company also finalizes its acquisition of Nextract, the developer behind these innovative formulations.