Latest Fda News

Artrya Limited has begun generating fee-per-scan revenues from its Salix Coronary Plaque module at Tanner Health in the U.S., marking a key commercial milestone for the AI-powered cardiac imaging platform.

EBR Systems has completed the first patient implant in its Totally Leadless CRT (TLC-AU) feasibility study, marking a strategic step toward expanding wireless cardiac resynchronisation therapy for heart failure patients.

EBR Systems has expanded its intellectual property holdings with four new patents, reinforcing its lead in wireless cardiac pacing technology, while facing a preliminary setback on a patent term extension application.

Argenica Therapeutics’ AI-powered reanalysis of its Phase 2 trial reveals significant efficacy of ARG-007 in severe acute ischemic stroke patients, highlighting improved functional outcomes and reduced brain damage.

Neurizon Therapeutics has secured FDA clearance for its lead drug candidate NUZ-001 to enter the HEALEY ALS Platform Trial, marking a key regulatory milestone and setting the stage for patient enrollment in early 2026.

InhaleRx advances its clinical pipeline with a new oral treatment for resistant depression and plans a strategic rebrand to Nexalis Therapeutics, signaling a broader focus beyond inhaled therapies.

LTR Pharma has received regulatory clearance from the Therapeutic Goods Administration to commence its Phase II clinical trial of SPONTAN, focusing on men aged 65 and over. Patient recruitment is set to begin early next year, aiming to address a key gap in erectile dysfunction treatment.

Immuron Limited reports topline results from a Uniformed Services University trial of a third-party ETEC product that missed its primary endpoint, reaffirming commitment to its established Travelan dosing ahead of FDA discussions.

InhaleRx Limited has secured $427,500 from an initial tranche of its $1 million capital raise, issuing 17.1 million shares to support its inhaled therapies targeting pain and mental health conditions.

Immutep has struck a strategic licensing deal with Dr. Reddy’s, granting rights to commercialise its novel cancer immunotherapy Eftilagimod Alfa across key emerging markets. The agreement includes a $20 million upfront payment and potential milestones exceeding $349 million.

Artrya Limited has landed a significant three-year commercial agreement with Northeast Georgia Health System, marking its second U.S. customer for the AI-powered Salix platform. This deal accelerates Artrya’s footprint in cardiovascular diagnostics across a major U.S. health network.

Imugene Limited has received positive feedback from the FDA, aligning key requirements to progress its azer-cel therapy into a pivotal clinical trial, underscoring its growing promise in blood cancer treatment.