Latest Fda News

Neurizon Therapeutics received FDA guidance on its IND application for NUZ-001, with a single request for additional animal exposure data but no safety concerns flagged. The company is actively addressing the FDA’s request while evaluating impacts on its ALS trial timeline.

The a2 Milk Company delivered solid first-half FY25 results with revenue up 10.1% and net profit rising 7.6%, driven by strong growth in China and the USA despite supply constraints and ANZ challenges. The company also declared its first-ever interim dividend and upgraded its full-year outlook.

The a2 Milk Company has reported robust first-half FY25 results, boosting full-year guidance and declaring its inaugural dividend, underscoring confidence in its growth trajectory.

Artrya Limited has launched a A$15 million capital raising to fund the development and commercial rollout of its Salix AI-powered coronary artery disease diagnostic platform, targeting the lucrative US healthcare market.

Artrya Limited has secured A$15 million through a two-tranche placement aimed at accelerating regulatory approvals and commercial rollout of its Salix® coronary artery disease diagnostic software in the US.

AVITA Medical reported a strong 30% increase in Q4 2024 commercial revenue and amended its credit agreement with OrbiMed to adjust revenue covenants through 2026. The company is poised for significant growth with new product rollouts and expects profitability by year-end 2025.

AVITA Medical's Q4 2024 earnings reveal strong commercial growth alongside the launch of Cohealyx, a novel collagen-based skin substitute that promises to transform acute wound care.

AVITA Medical reported a robust 30% increase in Q4 2024 commercial revenue alongside key FDA clearances, setting the stage for ambitious growth in 2025.

Island Pharmaceuticals has successfully completed patient dosing in the Phase 2b therapeutic arm of its PROTECT clinical trial for ISLA-101, targeting dengue fever treatment. High-level results are expected within two months, potentially advancing a significant antiviral candidate.

EMVision Medical Devices has secured US ethics approval for its pivotal multi-centre trial of the EMVision emu™ brain scanner, paving the way for a March 2025 trial start aimed at FDA clearance.

Gyder Surgical, backed by Hydrix Ventures, has secured FDA 510(k) clearance for its innovative GYDER Hip System, opening the door to the lucrative U.S. market and increasing Hydrix’s investment value.

Alterity Therapeutics has raised A$40 million through a two-tranche placement to advance its lead compound ATH434 for neurodegenerative diseases, including Multiple System Atrophy and Parkinson's disease.