Latest Fda News

EBR Systems has completed the first commercial US implants of its FDA-approved WiSE wireless cardiac resynchronization therapy system, marking a pivotal step toward broader market adoption and reimbursement.

Clarity Pharmaceuticals reports that its Cu-SARTATE diagnostic agent significantly outperforms the current standard in detecting neuroendocrine tumours, paving the way for a pivotal Phase III study.

PainChek has advanced its US regulatory approval process with a positive FDA meeting, setting the stage for a potential market debut of its pain assessment app in late 2025.

Chimeric Therapeutics has secured FDA Fast Track designation for its CHM CDH17 CAR-T therapy targeting gastroenteropancreatic neuroendocrine tumours, accelerating its path toward regulatory approval and patient access.

Mayne Pharma rebuffs Cosette's claim of a material adverse change in their merger scheme and secures FDA clearance on regulatory concerns, maintaining its commitment to the deal's completion.

Recce Pharmaceuticals has completed a A$15.8 million capital raise to fund pivotal Phase 3 clinical trials and progress its FDA application, positioning the company for potential commercial breakthroughs in antibiotic-resistant infections.

Paradigm Biopharmaceuticals has reached key milestones in its global Phase 3 trial for knee osteoarthritis, activating its first Australian clinical site and enrolling the first patient. With multiple sites in Australia and the US preparing for recruitment, the trial is advancing steadily toward critical data readouts.

EMVision Medical Devices has activated two additional key sites in its pivotal trial for the emu™ bedside brain scanner, advancing its path toward FDA clearance. These new sites join a growing network of leading stroke centres across the US and Australia.

INOVIQ Limited has revealed promising data for its EXO-OC™ ovarian cancer screening test, demonstrating exceptional accuracy and flawless detection of early-stage cancers. This innovation could transform early diagnosis and treatment outcomes for women worldwide.

Cardiex Limited has gained Therapeutic Goods Administration approval for its CONNEQT Pulse device, paving the way for commercial expansion in Australia alongside its established US presence.

Neurotech International has reported positive human pharmacokinetic results for NTI164, a cannabinoid formulation designed for paediatric neurological disorders, confirming rapid absorption and a non-intoxicating profile.

Lumos Diagnostics has reached 50% recruitment of bacterial positive patients in its pivotal FebriDx CLIA waiver clinical study, setting the stage for a planned FDA submission in late 2025 and unlocking a substantial US market opportunity.