Latest Fda News

Neurotech International has reported excellent safety and tolerability for its lead drug NTI164 in 28-day GLP toxicology studies, paving the way for regulatory submissions and longer-term clinical development.

4DMedical has landed a significant commercial contract with Intermountain Health to deploy its FDA-cleared Pulmonary Hypertension Analysis (PHA™) product, marking a key milestone in its U.S. expansion through a strategic Microsoft-backed partnership.

AdAlta Limited has announced a pro rata renounceable rights offer to raise approximately $1.29 million, aiming to fund its strategic pivot towards licensing CAR-T cell therapies through its subsidiary AdCella. The offer includes new shares and options, underpinned by key insiders and an underwriting agreement.

Neurizon Therapeutics has announced the successful completion of its Open-Label Extension study for NUZ-001 in ALS, revealing significant survival benefits and strong tolerability. The company is on track to release top-line results in Q3 2025 and advance to a pivotal Phase 2/3 trial.

Alterity Therapeutics has secured FDA Fast Track designation for ATH434, its lead candidate for treating Multiple System Atrophy, potentially speeding up regulatory review and bringing hope to patients with this rare neurodegenerative disorder.

Immutep’s combination of eftilagimod alfa (efti) and KEYTRUDA® delivers a striking 17.6-month median overall survival in head and neck cancer patients with low PD-L1 expression, a group with limited treatment options.

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.

Dimerix has inked an exclusive US licensing agreement with Amicus Therapeutics for DMX-200, a promising Phase 3 treatment for FSGS, unlocking $30 million upfront and up to $560 million in milestones.

Recce Pharmaceuticals reports strong Phase II clinical trial results for its topical anti-infective R327G, achieving a 93% efficacy rate in treating ABSSSI, alongside a significant capital raise to fund upcoming Phase III trials.

Clarity Pharmaceuticals reports a robust cash position and strategic refocus on its lead prostate cancer asset, Cu-SAR-bisPSMA, supported by multiple FDA Fast Track designations and advancing clinical trials.

SomnoMed Limited reported a robust 23.2% revenue increase in Q3 FY25, reaffirming its full-year guidance while actively addressing new US tariffs through potential duty-free exemptions.