Latest Regulatory Affairs News

Island Pharmaceuticals reports ongoing FDA review of its antiviral Galidesivir, with no adverse feedback received as the regulator takes extra time to finalise guidance.

Neurizon Therapeutics has progressed its ALS treatment NUZ-001 into critical clinical trial phases, even as the FDA declines its Fast Track Designation request pending more data.

Dimerix secures FDA confirmation that proteinuria reduction is a valid primary endpoint for its Phase 3 ACTION3 trial, advancing its kidney disease drug DMX-200 closer to approval.

InhaleRx Limited has successfully closed its entitlement offer and placement, raising $857,730 to support the clinical development of inhaled treatments targeting cancer pain and mental health conditions.

Actinogen Medical has finalized enrollment and begun treatment of all 246 participants in its XanaMIA Phase 2b/3 Alzheimer’s trial, with topline results expected in November 2026. The oral drug Xanamem targets brain cortisol to potentially slow disease progression.

Opthea Limited has announced a strategic pivot to develop OPT-302 for Lymphangioleiomyomatosis (LAM), a rare lung disease affecting women, aiming for ASX reinstatement in 2026. The company leverages strong intellectual property and cash reserves to pursue orphan drug designation and clinical development.

Dimerix has successfully completed recruitment and dosing of 286 adult patients in its Phase 3 ACTION3 trial evaluating DMX-200 for focal segmental glomerulosclerosis (FSGS), advancing toward regulatory discussions with the FDA.

EBR Systems has expanded its intellectual property holdings with four new patents, reinforcing its lead in wireless cardiac pacing technology, while facing a preliminary setback on a patent term extension application.

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.

Imugene has secured FDA backing to advance its allogeneic CAR T therapy, azer-cel, into a pivotal Phase 3 trial targeting difficult-to-treat diffuse large B-cell lymphoma (DLBCL), including patients relapsed after prior CAR-T treatment.

Telix Pharmaceuticals has dosed the first patient in the randomized expansion phase of its pivotal ProstACT Global Phase 3 trial for TLX591, targeting advanced prostate cancer. The trial is expanding globally, with regulatory submissions underway in the US and Europe.

Neurizon Therapeutics has completed manufacturing three GMP registration batches of its lead ALS drug candidate NUZ-001 ahead of schedule, paving the way for FDA submissions and clinical trial enrollment.