Latest Fda Approval News

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.

Mesoblast Limited reported a 60% jump in Ryoncil sales to US$35 million for the December quarter, alongside securing a US$125 million credit facility that enhances its financial flexibility and supports ongoing clinical development.

Imagion Biosystems has completed manufacturing its MagSense® HER2 imaging agent and is preparing for a key FDA submission, while appointing a new president to lead its US operations.

Dimerix Limited has completed recruitment for its pivotal ACTION3 Phase 3 trial targeting a rare kidney disease, secured positive FDA feedback on trial endpoints, and reported a solid cash position of AU$38.5 million at the end of 2025.

Acrux Limited reports solid revenue growth and increased cash reserves in the December quarter, driven by expanding its topical generics portfolio in the US and strategic moves into female Hormone Replacement Therapy.

PainChek has secured FDA-regulated medical device status, enabling US Remote Therapeutic Monitoring reimbursement and opening a major US growth avenue. The company targets musculoskeletal pain management in non-verbal dementia patients, a largely underserved market.