Latest Fda News

dorsaVi Ltd has unveiled Artemis Labs, a new subsidiary focused on developing advanced AI, sensor, and robotics technologies powered by cutting-edge RRAM. This initiative aims to transform human movement data into intelligent robotic and healthcare applications.

Argent BioPharma has signed a binding term sheet to acquire key assets from AusCann Group Holdings, significantly expanding its clinical pipeline, intellectual property, and European manufacturing and distribution capabilities ahead of a planned US stock exchange listing.

AdAlta Limited outlines its innovative 'East to West' cellular immunotherapy approach, in-licensing Asian CAR-T assets and progressing clinical trials in Australia to unlock value. The company also seeks partners for its anti-fibrotic and anti-malarial protein therapeutics.

ReNerve Limited has achieved a key milestone with its first sale and clinical use of a deep dermal tissue product in the US, broadening its surgical applications beyond nerve repair. This move complements its existing nerve repair portfolio and sets the stage for further product launches later this year.

Cleo Diagnostics has launched a health economic study in partnership with EntityRisk and Norstella to support the U.S. market entry of its Ovarian Cancer Pre-Surgical Test, aiming to refine reimbursement strategies and accelerate commercialisation.

Lumos Diagnostics has submitted its CLIA waiver application for FebriDx® to the FDA, backed by strong clinical data and triggering significant milestone payments. Approval could expand the U.S. market opportunity fifteen-fold to over $1 billion.

dorsaVi Ltd has raised A$5 million through a strategic placement to accelerate development of its next-generation RRAM-enabled sensors and robotics platforms, signaling a bold expansion into edge AI and neuromorphic computing.

Neurizon Therapeutics faces a delay in FDA review for its lead ALS therapy NUZ-001, with a new decision expected by early October amid agency-wide staffing challenges.

EMVision Medical Devices has been awarded a $3 million non-dilutive government grant to conduct a pioneering clinical study using its telehealth-enabled emu™ brain scanner in regional South Australia, aiming to transform stroke diagnosis and treatment.

Pro Medicus has delivered a landmark FY25 with soaring revenue and profit, driven by major contract wins and strategic cloud deployments. The company’s expanding North American footprint and AI initiatives set the stage for sustained growth.

Pro Medicus Limited reports a record-breaking year with $520 million in new contracts and a surge in cloud adoption, setting the stage for continued growth. The company also advances its AI and cardiology offerings, reinforcing its market position.

Argenica Therapeutics has received detailed FDA feedback outlining specific data requirements to lift the clinical hold on its ARG-007 stroke trial in the US, setting a clear path forward for its neuroprotective drug.