Latest Fda News

Imugene Limited reports promising Phase 1b trial results for azer-cel, an off-the-shelf CAR T therapy, showing a 75% overall response rate in relapsed diffuse large B-cell lymphoma patients. The company plans to engage the FDA later this year to discuss pivotal trial design.

Tissue Repair Limited has secured major distribution partnerships in Australia, New Zealand, and Thailand for its TR Pro+® product line, marking a pivotal shift from development to commercialisation. The company is also scaling up manufacturing and advancing regulatory approvals to support its global expansion ambitions.

Cambium Bio has secured FDA clearance to begin Phase 3 dosing of Elate Ocular, a promising treatment for moderate to severe dry eye disease, pending additional financing.

Imagion Biosystems has received encouraging feedback from the FDA on its planned Phase 2 HER2 breast cancer clinical trial, paving the way for its Investigational New Drug application submission later this year.

Neurizon Therapeutics has received positive feedback from the FDA on its plan to resolve the clinical hold on its ALS drug candidate NUZ-001, with key preclinical studies completed ahead of schedule. The company aims to resume clinical trials in late 2025.

Imricor Medical Systems has secured key European regulatory approvals for its second-generation NorthStar system and initiated its commercial launch, while US FDA submissions progress amid some delays.

Orthocell has achieved a significant milestone by recording its first US sales revenue for Remplir™, its flagship nerve repair product, shortly after FDA clearance and initial surgical use.

Artrya Limited has secured a five-year, US$0.6 million contract with Tanner Health, marking its inaugural commercial revenue in the U.S. market for its AI-powered Salix Coronary Anatomy platform.

Island Pharmaceuticals has accelerated its acquisition of the Galidesivir antiviral program from BioCryst Pharmaceuticals, adding a clinically advanced asset with significant US government backing and a promising regulatory pathway.

Orthocell Limited has reported a record FY2025 revenue of A$9.19 million, driven by strong sales of its nerve repair product Remplir™ in Australia and a promising US market launch following FDA clearance.

Vitasora Health has completed the first tranche of its $11 million capital raise, positioning the company to fund growth initiatives and reach cash flow breakeven in the second half of fiscal 2026.

BlinkLab has expanded its pivotal FDA autism diagnostic trial by adding the University of Nebraska Medical Center as a second U.S. clinical site, advancing toward broader validation and regulatory clearance.