Latest Fda News

Neurotech International has secured FDA clearance for its NTI164 Investigational New Drug application and obtained Notices of Allowance for two US patents, advancing its Phase 3 autism spectrum disorder program.

4DMedical has secured a pivotal three-year contract with SimonMed Imaging to deploy its CT:VQ™ lung imaging technology across over 170 US outpatient centres, while FY26 revenue rose 23% to $7.2 million on record scan volumes and global expansion.

Acrux Limited’s FY26 receipts soared 960% to $5 million, fuelled by licensing milestones and growing generic sales, while FDA guidance clears the way for pivotal Phase III trials of its Female Testosterone therapy.

Tissue Repair advances its US Phase III chronic wound trial with 100 patients randomised and targets October FDA 510(k) submission. The company reports a robust cash position bolstered by R&D refunds and has cut manufacturing scale-up costs.

Zelira Therapeutics has raised nearly US$33 million into its HOPE® 1 special purpose vehicle, valuing the SPV at about US$66 million post-money. The funds will advance FDA regulatory submissions and Phase 1 clinical trials for its autism-targeting cannabinoid drug.

Actinogen Medical’s pivotal XanaMIA Alzheimer’s trial stays on track for November topline results, buoyed by strong open-label extension enrolment and aligned EMA-FDA regulatory advice. A new antidepressant study publication and fresh patents add momentum, supported by a $16.7 million cash runway to mid-2027.

Mesoblast delivered US$115 million in Ryoncil® revenue in its first full year post-FDA approval, while expanding clinical trials into adult indications and acquiring cutting-edge CAR technology to boost its cell therapy pipeline.

Alterity Therapeutics has cleared a major regulatory hurdle with the FDA endorsing a single pivotal Phase 3 trial for its ATH434 drug in Multiple System Atrophy, setting the stage for trial initiation by the end of 2026.

Island Pharmaceuticals has marked a major step forward in its antiviral program with the start of GMP manufacturing for Galidesivir, expanded USAMRIID collaboration, and FDA orphan drug designation. Regulatory approvals for compassionate use in Uganda’s Ebola outbreak and a new dose optimisation study with Texas Biomed further de-risk the pathway to approval.

Dimerix Limited (ASX: DXB) has inked its fifth regional licensing agreement with Everest Medicines, boosting potential milestone payments to A$1.9 billion and expanded its kidney disease pipeline through the acquisition of DMX-652. The Phase 3 ACTION3 trial for DMX-200 remains statistically robust, with funding secured to advance both clinical programs.

OncoSil Medical reported a 53% increase in unit sales and advanced key regulatory approvals, including FDA final review and TGA listing, positioning it for growth in pancreatic cancer treatment.

Epiminder has leveraged its $125 million IPO to advance clinical enrolments, boost Medicare reimbursement, and develop its next-generation Minder device, positioning for a commercial launch in early 2028.