Latest Us Fda News

Bubs Australia has submitted critical clinical trial data to the US FDA, marking a pivotal step toward permanent approval for its infant formulas in the US market.

Argenica Therapeutics faces a clinical hold from the US FDA on its stroke drug trial application, though its Australian Phase 2 study remains unaffected and on track.

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.

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.

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.

Recce Pharmaceuticals has secured a significant patent acceptance in China for its RECCE® anti-infectives, broadening its intellectual property footprint in the world’s second-largest pharmaceutical market.

Paradigm Biopharmaceuticals has secured centralised US ethics approval for its pivotal Phase 3 trial of injectable pentosan polysulfate sodium (iPPS) targeting moderate to severe knee osteoarthritis, setting the stage for patient enrolment in Q3 2025.

Orthocell has rapidly expanded its US distributor network for Remplir™, surpassing its target ahead of schedule and positioning itself for imminent sales in the $1.6 billion nerve repair market.

Alterity Therapeutics is set to present compelling Phase 2 clinical trial results for ATH434 at the 2025 International Multiple System Atrophy Congress, highlighting slowed disease progression and biomarker engagement in MSA patients.

BlinkLab Limited has raised A$7.66 million through a well-supported placement to accelerate FDA regulatory trials for its autism and ADHD diagnostic platforms, leveraging its innovative smartphone-based technology.

Dimerix Limited has announced a US licensing transaction for its Phase 3 asset DMX-200 targeting FSGS, alongside progress updates on its clinical trial. The move underscores the company’s push to address a rare kidney disease with no approved therapies.