Latest Fda Approval News

LTR Pharma reports strong Q1 2025 progress with FDA pre-IND meeting success, scientific acclaim for SPONTAN’s rapid absorption, and strategic launch of ROXUS to fast-track US market entry.

Nyrada Inc. posted a significant $2.46 million loss for H1 FY25, driven by increased R&D spend, while advancing its lead drug NYR-BI03 into first-in-human trials following regulatory approval.

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

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.

Cleo Diagnostics has responded to an ASX price query following a notable rise in its share price and trading volume, underscoring its patented ovarian cancer detection technology and ongoing U.S. clinical trials.

Acrux Limited announces the retirement of CEO Michael Kotsanis after more than 10 years at the helm, with a search underway for his successor to lead the next phase of growth.

Cleo Diagnostics reports steady progress in its U.S. and Australian clinical trials for an ovarian cancer blood test, maintaining a solid cash reserve of A$7.3 million as it prepares for FDA submission.

Echo IQ confirms the material significance of its pre-submission FDA meeting for EchoSolv HF, marking a pivotal step toward US market entry and commercialisation.

Visioneering Technologies reported a mixed Q4 FY'24 with a slight revenue decline but stronger cash flow and expanding global footprint, underpinned by promising clinical trial data.