Latest Us Fda News

Optiscan Imaging Ltd has initiated Australia’s first intra-operative head and neck cancer imaging study using its advanced InVue® and InForm™ devices, aiming to enhance surgical precision and support FDA regulatory submissions.

Recce Pharmaceuticals has secured a key patent in Hong Kong for its synthetic anti-infectives, reinforcing its intellectual property footprint in Asia and supporting its clinical and commercial ambitions in the region.

InhaleRx Limited has introduced SRX-25, an oral fixed-dose combination therapy targeting Treatment-Resistant Depression, aiming to improve patient access and adherence. The company also secured $1 million in capital to advance clinical development and plans a strategic rebrand.

Cleo Diagnostics has secured a $1.7 million R&D tax refund, strengthening its cash reserves to $5.75 million as it advances toward a pivotal US clinical trial and FDA submission for its ovarian cancer test.

Zelira Therapeutics has received a $1.07 million cash refund under Australia’s R&D Tax Incentive Scheme, reinforcing its funding for ongoing clinical trials and product development. The company has also repaid a prior loan advanced against this claim, positioning it for continued growth in cannabinoid-based medicines.

Amplia Therapeutics has secured positive feedback from the US FDA on its Phase 2b/3 trial design for narmafotinib in pancreatic cancer, paving the way for a late 2026 trial start.

AFT Pharmaceuticals delivered a robust first half for FY26, posting 33% revenue growth and a return to profitability, driven by strong Australian sales and recovery in Asia and international markets. The company is advancing its global footprint and R&D pipeline, positioning for sustained growth.

Prescient Therapeutics has achieved a key regulatory milestone with the European Medicines Agency granting Orphan Drug Designation for its PTX-100 therapy targeting Cutaneous T-cell Lymphomas, enhancing its commercial and clinical prospects in Europe.

Race Oncology has announced pivotal new clinical trials for its lead asset RC220, aiming to accelerate regulatory approval in Acute Myeloid Leukemia and tackle resistance in Non-Small Cell Lung Cancer.

Argenica Therapeutics reports ARG-007 is safe in acute ischemic stroke patients and shows promising efficacy signals in a high-risk subgroup, paving the way for a focused Phase 2b trial.

PainChek has secured FDA De Novo clearance for its Adult App, opening immediate access to a $175 million AUD US long-term care market and advancing its Infant App commercialization targeting a $15 billion AUD global opportunity.

Percheron Therapeutics reports encouraging phase I clinical results for HMBD-002, confirming safety and early efficacy signals, while gearing up for a multi-arm phase II trial in 2026.