Latest Fda News

Immutep Limited advances its pivotal Phase III lung cancer trial and reports promising results across multiple oncology and autoimmune programs, supported by a solid cash position to fund operations through 2026.

EMVision Medical Devices reports strong progress in its pivotal trial for the emu™ bedside brain scanner and successful aeromedical testing of its First Responder device, backed by a $5 million government grant and $10.5 million in cash reserves.

Chimeric Therapeutics has advanced its CHM CDH17 CAR-T program with dose escalation and FDA Fast Track status, alongside promising early results in AML trials and a successful $6.6 million capital raise.

Radiopharm Theranostics reports significant progress in its oncology radiopharmaceutical pipeline, including FDA Fast Track designation and dose escalation approvals, supported by a solid cash runway through mid-2026.

Prescient Therapeutics has raised $6.8 million through a Share Purchase Plan to fund the Phase 2 development of its novel cancer therapy PTX-100, while launching a discounted placement to sophisticated investors.

Atomo Diagnostics reports strong commercial momentum in Q4 FY25, highlighted by a major US supply agreement, rapid growth in HIV self-test sales, and promising data for its syphilis test.

Syntara Limited has initiated dosing in its Phase 1a/b trial for SNT-9465, a topical drug targeting hypertrophic scars, aiming to offer a non-invasive alternative to current treatments. Results expected in early 2026 could pave the way for global development and FDA approval.

Imagion Biosystems has made significant progress towards filing an Investigational New Drug application for its MagSense® HER2 breast cancer imaging agent, receiving encouraging feedback from the FDA and preparing for a Phase 2 clinical trial.

Paradigm Biopharmaceuticals has advanced its global Phase 3 trial for knee osteoarthritis pain with active patient recruitment in Australia and the US, backed by a $41.2 million convertible note facility. The company also expanded its osteoarthritis portfolio through the acquisition of Proteobioactives and the Pentacoxib™ oral therapy.

SomnoMed reports a robust Q4 FY25 with 25% revenue growth and a milestone of treating over 1 million patients, while gearing up for significant capacity expansion and clinical advancements.

LTR Pharma has initiated commercial distribution of its nasal spray SPONTAN through Australia's Symbion pharmacy network and is advancing ROXUS development for a US launch in early 2026, while expanding its pipeline with a new intranasal treatment for swallowing disorders.

EMVision Medical Devices has secured ethics approvals for two pivotal clinical studies and received a $400,000 milestone payment, marking significant progress toward commercialising its portable First Responder brain scanner.