Latest Fda News

Alterity Therapeutics reported a reduced net loss of A$12.15 million for FY2025, buoyed by positive Phase 2 clinical trial results for its lead drug ATH434 in Multiple System Atrophy and a successful A$40 million capital raising.

4DMedical reports a robust 56% revenue increase in FY2025, driven by SaaS expansion and strategic partnerships, while advancing FDA clearance for its innovative CT – VQ™ lung imaging software.

4DMedical Limited reported a 56% jump in FY2025 operating revenue driven by SaaS growth, while narrowing its net loss to $30.1 million. The company also secured $13.9 million in capital and a $10 million funding facility to accelerate product commercialisation.

Bubs Australia Limited reports a striking turnaround in FY25 with revenue up 29% to $102.5 million and net profit soaring 124% to $5.17 million, driven by strong US and China growth. The company awaits permanent FDA approval, a pivotal factor for its future trajectory.

Immuron Ltd reported a robust 49% increase in FY25 global sales, driven by strong Travelan® growth, while gearing up for a ProIBS launch and pivotal FDA meetings in 2025-26.

Mayne Pharma Group Limited reported a robust FY25 with a 5% revenue increase to A$408.1 million and a 105% surge in underlying EBITDA, driven by strong growth in Women’s Health and strategic acquisitions in Dermatology.

Acrux Ltd reported a 44% revenue decline and a modest increase in net loss for FY25, while expanding its US topical generics portfolio and entering the Saudi Arabian market. The company signals a strategic pivot amid intensifying competition and lower returns.

LTR Pharma’s FY25 results reveal a transformative year highlighted by SPONTAN’s rapid absorption and strategic partnerships that pave the way for US market entry.

LTR Pharma Limited (ASX, LTP) reported significant progress in FY25, advancing its novel intranasal treatments for erectile dysfunction and expanding its commercial footprint in Australia and the US. The company secured key partnerships and capital raises, positioning itself for regulatory milestones and global market entry.

Mesoblast Limited marked a transformative year with FDA approval and commercial launch of Ryoncil, its first mesenchymal stromal cell therapy, driving a 191% jump in cell therapy revenues. The company is now poised to expand its footprint in inflammatory diseases with multiple clinical trials and label extensions underway.

PainChek Limited reported a 24% revenue increase to $4.8 million for FY25, narrowing its net loss by 7%, while progressing toward FDA clearance for its Adult PainChek App in the US and launching its Infant App in Australia.

Mesoblast reports a strong FY2025 financial performance driven by the commercial launch of Ryoncil, the first FDA-approved mesenchymal stromal cell therapy for steroid-refractory acute graft-versus-host disease in children. The company is advancing multiple clinical programs targeting inflammatory diseases, heart failure, and chronic low back pain.