Latest Fda News

Cleo Diagnostics has responded to an ASX price query following a notable rise in its share price and trading volume, underscoring its patented ovarian cancer detection technology and ongoing U.S. clinical trials.

Neuren Pharmaceuticals has received a significant cash inflow of approximately US$50 million following the sale of a Priority Review Voucher linked to its Rett syndrome treatment. This milestone underscores the growing value of Neuren’s neurological drug portfolio and its partnership with Acadia Pharmaceuticals.

Acrux Limited announces the retirement of CEO Michael Kotsanis after more than 10 years at the helm, with a search underway for his successor to lead the next phase of growth.

Neuren Pharmaceuticals has secured a pivotal FDA Type C Meeting to discuss primary efficacy endpoints for its Phase 3 trial of NNZ-2591 targeting Phelan-McDermid syndrome, advancing its rare disease drug development.

ImpediMed Limited has locked in a US$15 million growth capital facility with SWK Funding LLC, providing crucial financial flexibility to advance its SOZO Digital Health Platform and commercial ambitions.

AdAlta has fast-tracked its cellular immunotherapy growth by signing two new term sheets for clinical-stage CAR-T products from Asia, pivoting to focus on in-licensing and clinical trials while winding down internal R&D on its antifibrotic drug AD-214.

Vitrafy Life Sciences reported a dramatic increase in half-year losses to $25.7 million, yet successfully raised $35 million through an IPO to fuel its cryopreservation technology expansion.

Neurizon Therapeutics has been granted a pivotal US patent for its lead drug candidate NUZ-001, extending protection until 2039 and enhancing its commercial and clinical positioning in neurodegenerative disease treatment.

Alterity Therapeutics has raised over A$2 million through its U.S. ATM facility and expects nearly A$5.7 million in Australian tax rebates, fueling the advancement of its lead neurodegenerative drug candidate ATH434 following promising Phase 2 results.

dorsaVi has secured a new commercial research project with renowned US surgeon Dr. Chirag Patel, leveraging its FDA-cleared wearable sensor technology and AI to enhance injury prevention and performance for elite athletes.

Cardiex has kicked off deliveries of its CONNEQT Pulse arterial health monitors in the U.S., reporting strong preorder momentum and a 150% sales increase in December. The company’s strategic operational shifts and pharma partnerships set the stage for sustained growth in 2025.

Paradigm Biopharmaceuticals has launched a Loyalty and Piggyback Options program aimed at rewarding shareholders and raising up to $111.96 million to support its pivotal Phase III clinical trial.