Latest Fda News

EMVision Medical Devices has secured US ethics approval for its pivotal multi-centre trial of the EMVision emu™ brain scanner, paving the way for a March 2025 trial start aimed at FDA clearance.

Gyder Surgical, backed by Hydrix Ventures, has secured FDA 510(k) clearance for its innovative GYDER Hip System, opening the door to the lucrative U.S. market and increasing Hydrix’s investment value.

Alterity Therapeutics has raised A$40 million through a two-tranche placement to advance its lead compound ATH434 for neurodegenerative diseases, including Multiple System Atrophy and Parkinson's disease.

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.