Latest Fda News

Mesoblast has completed treatment of 300 patients in its pivotal Phase 3 trial for rexlemestrocel-L, targeting chronic low back pain due to degenerative disc disease, with topline results expected mid-2027.

Recce Pharmaceuticals has expanded its intellectual property footprint with a key patent granted in Vietnam for its RECCE® anti-infective drugs, reinforcing its presence in a critical Southeast Asian market grappling with high antibiotic resistance.

Neurotech International has secured FDA clearance for its Investigational New Drug application for NTI164, enabling clinical development in the US and advancing its global registration and commercialisation plans.

Orthocell Ltd delivered a standout FY26 with 44% revenue growth to A$13.2 million, powered by accelerating US sales of its nerve repair product Remplir and a robust cash position supporting further expansion.

Vectus Biosystems has appointed Cardinal Health Regulatory Services as its US regulatory agent to manage FDA submissions for its lead fibrosis drug VB0004, marking a pivotal step towards clinical development in the US.

Island Pharmaceuticals has secured a critical collaboration with Texas Biomedical Research Institute to advance dose optimisation for its antiviral Galidesivir, targeting Marburg Virus Disease under the FDA Animal Rule. This second phase complements ongoing USAMRIID efforts and aims to de-risk pivotal study design with data from 32 non-human primates.

Immutep’s INSIGHT-003 trial shows promising overall survival in first-line non-squamous NSCLC, yet the Phase III TACTI-004 trial was discontinued following a futility analysis. Ongoing root cause investigations aim to clarify the divergent outcomes.

Cleo Diagnostics (ASX:COV) has entered the analytical validation phase for its ovarian cancer test, progressing toward an FDA 510(k) submission expected in early 2027.

Orthocell Limited has posted record revenue for FY2026, driven by strong sales growth of Remplir™ and Striate+™ products in Australia, the US, and new international markets, supported by a robust $44.1 million cash position.

OncoSil Medical has completed key manufacturing validation cycles with Cyclotek, paving the way for scalable Australian production of its OncoSil™ device. With a $2.1 million capital investment, the company aims to boost margins and supply chain control ahead of commercial launch in late 2026.

Mesoblast Limited’s Ryoncil® posted US$36 million in Q4 revenue, driving a full-year total of US$115 million, exceeding initial forecasts. The FDA-approved stem cell therapy for pediatric graft-versus-host disease shows robust uptake across US pediatric centres.

ReNerve has locked in a flexible A$5 million convertible note facility with RiverFort, drawing an initial A$1.6 million to back its commercial push and US sales ramp-up.