Latest Us Fda News

Atomo Diagnostics reported strong commercial momentum in Q1 FY26, highlighted by a key FDA submission for its FebriDx test and a successful capital raise of $1.3 million. The company also showcased promising clinical data for its Active Syphilis test and expanded its HIV Self-Test distribution channels.

Neurotech International has initiated an Authorised Prescriber program for its lead therapy NTI164, expanding access for children with neurodevelopmental disorders in Australia. The company also secured a Rare Pediatric Disease Designation from the US FDA for NTI164 in Rett Syndrome, marking a key regulatory milestone.

Optiscan Imaging Ltd secured $17.75 million in a fully underwritten equity raise, fueling clinical studies and regulatory preparations for its innovative medical imaging devices. The company also reported progress in international trials and strengthened its cash position to nearly $20 million.

Arovella Therapeutics has secured encouraging feedback from the US FDA on reagent testing for its CAR-iNKT cell therapy, setting the stage for an IND filing this quarter and clinical trials in early 2026.

AdAlta Limited has fully repaid its remaining NLSC investment in cash, ending its obligation to issue further shares and positioning itself for private capital raises to advance its CAR-T therapies.

Nexsen Limited has initiated clinical trials for its StrepSure® GBS Rapid Sensor, a next-generation diagnostic device aimed at improving maternal health outcomes. The trial's success could pave the way for regulatory approval and early market penetration by the second half of 2026.

Algorae Pharmaceuticals has signed a binding term sheet with India’s Cadila Pharmaceuticals to introduce two generic medicines targeting cardiovascular and metabolic disorders in Australia and New Zealand.

Orthocell has raised $30 million through an institutional placement to accelerate the US commercialisation of its flagship nerve repair product Remplir and expand its regenerative medicine portfolio.

Anteris Technologies has secured its first European regulatory clearance to commence the global PARADIGM Trial for its DurAVR Transcatheter Heart Valve, marking a significant step toward worldwide commercialization.

Biotron Limited is set to acquire Sedarex Limited, gaining global patents for SedRx, a next-generation general anaesthetic, supported by a $2.5 million capital raising to fund regulatory and development milestones.

Recce Pharmaceuticals has initiated patient dosing in its pivotal Phase 3 trial for diabetic foot infections in Indonesia, targeting a significant market with high diabetes prevalence. Interim results expected in early 2026 could accelerate regulatory approval and commercial launch.

Race Oncology has secured Investigational New Drug approval from South Korea’s regulatory authority, enabling Phase 1 clinical trials of RC220 in combination with doxorubicin for solid tumour patients across four Korean sites.