Latest Us Fda News

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.

Syntara Limited has made significant strides in its clinical pipeline, launching new trials and receiving key regulatory designations, positioning 2026 as a pivotal year for the company.

Imagion Biosystems has completed manufacturing its MagSense® HER2 imaging agent and is preparing for a key FDA submission, while appointing a new president to lead its US operations.

CurveBeam AI reported steady device orders alongside a $4 million milestone payment from its China commercialisation deal, while progressing FDA clearance and robotic surgery system validation.

AdAlta Limited has aligned its AdCella manufacturing strategy with new US FDA guidelines, made a significant milestone payment to Shanghai Cell Therapy Group, and secured an additional R&D tax rebate, marking key progress in its cellular immunotherapy pipeline.

Mesoblast has received encouraging feedback from the FDA on its cell therapy rexlemestrocel-L, showing meaningful pain relief and potential opioid use reduction in chronic low back pain patients. The company’s ongoing Phase 3 trial aims to confirm these benefits and advance regulatory approval.

Neuren Pharmaceuticals has affirmed the material impact of Acadia’s projection that DAYBUE global net sales could reach approximately US$700 million by 2028, underpinning its royalty revenue outlook.

Orthocell Limited has reported a record $3.2 million revenue for the December 2025 quarter, marking its seventh consecutive quarter of growth, fuelled by expanding sales of its nerve repair product Remplir in the US and other international markets.