Latest Fda News

dorsaVi has qualified three RRAM material stacks compatible with standard foundry processes, paving the way for scalable 22nm RRAM production and advancing its wearable robotics and medical sensor ambitions.

Atomo Diagnostics has closed a modest Share Purchase Plan, raising $44,500 and issuing free attaching options, while reserving a substantial shortfall for future placement.

Lumos Diagnostics has reached a key enrolment milestone in its BARDA-backed FebriDx paediatric trial, unlocking a US$670,000 payment and advancing its FDA submission pathway to expand use in children aged 2-12 years.

Neurizon Therapeutics has gained ethics approval to start a Phase 1 trial of its NUZ-001 oral liquid formulation, aiming to ease treatment for ALS patients with swallowing difficulties.

Nexsen has secured a strategic partnership with GHK Hospital Limited in Hong Kong, marking a significant step in validating and commercialising its rapid point-of-care diagnostics across North Asia.

EBR Systems accelerated its U.S. commercial rollout of the WiSE CRT System in Q1 2026 with implant volumes more than doubling and revenue hitting US$2.4 million. The company also secured a key regulatory milestone in Australia with TGA Priority Review, yet losses deepened and cash burn intensified, raising fresh questions about its funding runway.

EMVision is broadening its emu™ Pivotal Trial to include acute ischaemia detection, aiming to accelerate FDA clearance and enhance the brain scanner's clinical impact. Recruitment has passed 125 patients across US and Australian sites, with full enrolment expected by early 2027.

Neuren Pharmaceuticals saw a 20% jump in Q1 2026 DAYBUE net sales to US$101 million, with royalties up 23%. The Japan trofinetide trial has been fast-tracked, and the new powder formulation DAYBUE STIX gains early traction.

Arovella Therapeutics has named Dr Nicole Van Der Weerden as acting CEO following Dr Michael Baker’s departure, positioning her to steer the company through the critical phase I trial of its CAR-iNKT therapy ALA-101.

dorsaVi has initiated its Ultra-Edge Modular Design program, transitioning from IP development to a manufacturable hardware platform targeting robotics, exoskeletons, and industrial AI with ultra-low power consumption.

Anteris Technologies has treated the first US patients in its global PARADIGM trial, marking a key milestone in testing its DurAVR transcatheter heart valve against established devices.

Noxopharm is gearing up for a pivotal pre-IND meeting with the US FDA, enlisting global CRO Novotech to sharpen its regulatory approach for SOF-SKN, a drug targeting autoimmune skin diseases.