Latest Us Fda News

Recce Pharmaceuticals is progressing its Phase 3 clinical trial of RECCE 327, a novel synthetic antibiotic targeting multidrug-resistant infections, with interim data from Indonesia supporting registration plans across ASEAN by 2026.

Percheron Therapeutics reports a 64% reduction in half-year losses to $3.1 million, driven by progress in its licensed immuno-oncology drug HMBD-002 and a strategic pivot away from discontinued assets.

Prescient Therapeutics reported a 62.8% increase in half-year losses to nearly $4 million, driven by intensified clinical development of its PTX-100 cancer therapy. The company bolstered its balance sheet with a $9.85 million capital raise while securing key regulatory milestones in Europe and the US.

Neurotech International has reported positive long-term safety results for its lead drug candidate NTI164, bolstering its path towards regulatory approval and chronic use in paediatric neurological disorders.

Clarity Pharmaceuticals reports another metastatic prostate cancer patient achieving undetectable disease markers in its Phase II SECuRE trial, reinforcing promising efficacy and safety of its Cu-SAR-bisPSMA radiopharmaceutical.

AdAlta Limited reported a $2.44 million loss for H1 FY26 while progressing a key CAR-T therapy collaboration and raising $2.8 million in capital. The company’s ‘East to West’ immunotherapy strategy gains momentum with regulatory tailwinds and cost efficiencies.

Clarity Pharmaceuticals’ Cu-64 SAR-bisPSMA diagnostic agent significantly outperformed the current standard Ga-68 PSMA-11 in detecting prostate cancer recurrence, more than doubling lesion and patient detection rates in a pivotal head-to-head trial.

Neuren Pharmaceuticals has received detailed feedback from the US FDA on its clinical development plans for NNZ-2591 targeting hypoxic ischemic encephalopathy and Pitt Hopkins syndrome, paving a clearer path forward despite some delays.

Neurotech International has secured ethics approval to launch its Beyond Harmony Phase 3 clinical trial of NTI164 for autism spectrum disorder, marking a key step toward regulatory submissions in Australia and the US.

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.

AdAlta Limited has launched its 'East to West' cellular immunotherapy operations through a strategic collaboration with Shanghai Cell Therapy Group to co-develop BZDS1901, an innovative CAR-T therapy targeting mesothelioma and other solid cancers. The company also strengthened its balance sheet by raising $2.8 million via private placements and repaying key investment agreements.

Avecho Biotechnology is on the cusp of completing patient dosing in its pivotal Phase III CBD insomnia trial, backed by a recent $2.5 million capital raise and patent allowances in the US and Europe.