Latest Fda News

Arovella Therapeutics reported a robust $20.9 million cash position as it prepares for its first-in-human trial of ALA-101 and expands its solid tumour pipeline through new licensing agreements and leadership appointments.

Alterity Therapeutics has reported encouraging topline results from its open-label Phase 2 trial of ATH434 in advanced Multiple System Atrophy, showing slowed disease progression and biomarker stabilization.

PainChek Limited has raised A$7.5 million through a strongly supported placement to accelerate its US market entry following anticipated FDA clearance and expand its innovative AI pain assessment technology internationally.

Bubs Australia Limited reports a strong FY25 with 29% revenue growth to $102.5 million, positive EBITDA turnaround, and sustained cash flow improvements. The company also advances its US market ambitions with a key FDA submission underway.

Artrya has launched its AI-powered Salix Coronary Anatomy platform in the U.S. and submitted its Coronary Plaque module for FDA clearance, marking a key step in its commercial expansion. A new five-year contract with Tanner Health signals the start of U.S. revenues.

Radiopharm Theranostics has received FDA clearance to begin a Phase I clinical trial for RV-01, a novel radiopharmaceutical targeting the 4Ig isoform of B7-H3 in solid tumors, marking a significant step forward in cancer treatment innovation.

Imricor Medical Systems reported significant regulatory and commercial progress in Q2 CY25, including CE mark approvals and expanded clinical trials, while maintaining a strong cash position.

Neurizon Therapeutics has formally responded to the FDA's clinical hold on its lead ALS drug NUZ-001, submitting new animal safety data. The company aims to join the HEALEY ALS Platform Trial by late 2025, pending regulatory approval.

BlinkLab is advancing its FDA 510(k) clinical trials for autism and ADHD diagnostics, completing its U.S. autism pilot phase and expanding European ADHD recruitment. A recent $7.66 million capital raise supports these efforts as the company targets regulatory approvals in 2026.

Dimerix has secured a significant licensing agreement with Amicus Therapeutics for its kidney disease drug candidate DMX-200 in the US, receiving a US$30 million upfront payment and advancing its Phase 3 trial with FDA endorsement of a key clinical endpoint.

Singular Health has landed a pivotal $2 million US pilot contract with Provider Network Solutions and completed an $8 million capital raise, advancing its medical imaging platform’s regulatory and product development milestones.

Echo IQ has secured a strategic collaboration with the Mayo Clinic Platform and raised $17.3 million, advancing its AI-driven cardiology tools towards FDA clearance and US commercial scale.