Latest Fda 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.

Recce Pharmaceuticals has secured a second Cooperative Research and Development Agreement with the U.S. Army Institute of Surgical Research to test its RECCE 327 Gel in burn wound infection models, underscoring growing military interest in its synthetic anti-infectives.

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.

Tissue Repair’s December quarter update reveals a cautious path forward for its Phase 3 TR987 trial amid slow patient recruitment, while its TR Pro+ product line gains momentum through a new distributor partnership and upcoming product launches.

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.

Recce Pharmaceuticals progresses its Phase 3 diabetic foot infection trial in Indonesia, reports promising preclinical data for inhaled RECCE 327, and secures significant R&D funding and patent protection.

Clarity Pharmaceuticals reports robust progress in prostate cancer and neuroendocrine tumour trials alongside a strong cash position of $226.2 million, underpinning its path towards commercialisation.

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.

4DMedical has rapidly commercialised its CT – VQ™ lung imaging technology following FDA clearance, securing major partnerships and regulatory approvals that position it for significant growth in North America.

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.

Actinogen Medical’s pivotal XanaMIA trial for Alzheimer’s disease has received a green light from its independent Data Monitoring Committee to continue, reinforcing confidence in the drug’s safety and efficacy profile.