Latest Fda Approval News

Cyclopharm Limited is accelerating its US market push for Technegas with a A$16 million capital raise following a record 2025 sales performance. The company aims to expand its US installations and advance new clinical applications beyond pulmonary embolism.

Island Pharmaceuticals has raised $9 million to advance its antiviral drug Galidesivir through the FDA’s Animal Rule pathway, targeting inclusion in the US Strategic National Stockpile for biodefense viruses.

Island Pharmaceuticals secures FDA confirmation on Galidesivir’s development under the Animal Rule, unlocking a streamlined two-stage approval process and significant commercial incentives.

Imricor Medical Systems has welcomed Oklahoma Heart Institute as the fourth U.S. site in its pivotal VISABL-AFL clinical trial, accelerating patient recruitment and the FDA approval pathway for its MRI-guided cardiac ablation technology.

Cyclopharm has reported a record $32.3 million in operating revenue for FY2025, led by explosive growth in its U.S. Technegas market following FDA approval. The company reaffirms its ambitious target of 250–300 U.S. installations by mid-2026 amid strong clinical momentum.

Imagion Biosystems has submitted its Investigational New Drug application to the U.S. FDA for its MagSense® HER2 Imaging Agent, marking a pivotal step toward launching a Phase 2 clinical trial for breast cancer detection.

Orthocell Ltd reports steady progress in commercialising its nerve repair product Remplir in the US, with sales growth, expanded distributor networks, and manufacturing upgrades underpinning its path to profitability.

4DMedical Limited has responded to ASX queries over its announcements of commercial agreements with leading US academic medical centres, clarifying its disclosure approach and denying ramping allegations ahead of a $150 million capital raise.

Bubs Australia reports a 14% increase in half-year revenue, powered by a 47% jump in US sales, while other regions face challenges. The company remains optimistic about FDA approval and market recovery in H2 FY26.

4DMedical has secured a commercial contract with University of Chicago Medicine to deploy its CT, VQ™ lung imaging technology, marking the fifth major US academic medical centre to adopt the platform since FDA clearance.

Alterity Therapeutics has bolstered its Phase 2 data for ATH434 in Multiple System Atrophy and is advancing regulatory plans for a pivotal Phase 3 trial, supported by a robust cash position of A$49.2 million.

PainChek has secured FDA De Novo clearance, enabling entry into the vast US healthcare market with a $3 billion Remote Therapeutic Monitoring opportunity. The company reports $5.6 million contracted ARR and a strong global footprint in aged care.