Latest Fda News

Neurotech International reports key clinical progress in paediatric neurological disorders, securing FDA orphan drug designation for its Rett Syndrome treatment and advancing pivotal trials for ASD and PANDAS/PANS.

PYC Therapeutics reports substantial progress across all four of its drug development programs in Q4 2024, including key regulatory designations and clinical milestones that set the stage for pivotal trials in 2025.

Neurizon Therapeutics reports encouraging 8-month interim results for its ALS drug NUZ-001, secures Orphan Medicinal Product Designation in Europe, and raises $885,000 through a share placement, maintaining a robust $14 million cash position.

CurveBeam AI Limited reported a remarkable 150% increase in device purchase orders in Q2 FY25, driven by strong demand for its HiRise™M platform and a new commercial agreement with Stryker. The company is advancing validation of its Enhanced HiRise™ for robotic surgical systems, despite a regulatory delay for its BMD SaaS module.

Algorae Pharmaceuticals reports robust progress in its drug development pipeline, highlighted by promising preclinical results for cardiovascular and dementia candidates and significant AI platform enhancements.

CurveBeam AI has reported a record quarter for HiRise™ device purchase orders, driven by a strategic expansion with Stryker in Australia and New Zealand. The company also advanced its FDA regulatory pathway for its BMD module, setting sights on mid-2025 submission.

Universal Biosensors is expanding its handheld testing portfolio with the upcoming AQUASCOUT water sensor and growing sales of its FDA-approved Xprecia Prime blood coagulation device, targeting multi-billion-dollar markets.

Syntara Limited has reported encouraging interim Phase 2 trial results for its lead drug candidate SNT-5505 in myelofibrosis, alongside a successful A$15 million capital raise to advance multiple clinical programs.

4DMedical reports a remarkable 202% increase in Q2 FY2025 operating revenue, driven by rapid site expansion and key collaborations with leading healthcare providers and the U.S. Department of Defense.

Opthea Limited has spotlighted Sozinibercept as a potential game-changer in wet age-related macular degeneration (AMD) therapy, presenting compelling clinical data and a clear path to U.S. market entry.

TrivarX has secured positive feedback from the FDA on its pivotal trial design for MEB-001, an AI-driven algorithm targeting major depressive episode screening via sleep study data. The company is advancing site collaborations to launch a large-scale US trial.

Clarity Pharmaceuticals will present compelling data on its 64Cu-SAR-bisPSMA diagnostic agent at two leading oncology conferences, highlighting earlier and more accurate prostate cancer lesion detection than current standards.