Latest Fda News

BlinkLab Limited has secured independent scientific validation for its smartphone-based autism diagnostic technology through publication in the prestigious journal Autism Research, marking a significant milestone ahead of its FDA regulatory trial.

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

AdAlta Limited and its subsidiary AdCella have partnered with Shanghai Cell Therapy Group to co-develop a pioneering CAR-T cancer therapy targeting solid tumours outside China. This collaboration aims to bring a novel, armored immunotherapy with promising clinical results to global markets.

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.

Arovella Therapeutics has taken a significant step forward by submitting an IND application to the U.S. FDA for its lead CAR-iNKT cell therapy, ALA-101, targeting blood cancers. This milestone paves the way for a first-in-human Phase 1 trial in both Australia and the U.S.

Mesoblast has refinanced its senior debt with a new US$125 million, five-year credit facility that lowers borrowing costs and preserves key assets, positioning the company for strategic growth.

Clarity Pharmaceuticals’ novel diagnostic agent Cu-SAR-bisPSMA has been selected for oral presentation at the prestigious European Association of Urology Congress 2026, following promising Phase II trial results demonstrating superior detection of prostate cancer recurrence.

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.

The FDA’s recent ruling classifying traditionally prepared kava beverages as food under U.S. law clears a major regulatory hurdle for The Calmer Co, accelerating its growth on Amazon and strengthening its U.S. expansion strategy.

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.

Neurizon Therapeutics has launched a A$24.2 million equity raise to fund the next phase of clinical trials for its lead drug NUZ-001 targeting ALS, supported by a global licensing deal and a flexible convertible note facility.

Saluda Medical has received CE certification for its EVA™ Sensing Technology, enabling commercialisation in Europe and recognition in Australia following prior FDA approval. This milestone sets the stage for a broader rollout of its personalised spinal cord stimulation therapy in early 2026.