Latest Fda Approvals News

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.

Mesoblast Limited is set to launch Ryoncil®, the first FDA-approved MSC therapy for pediatric steroid-refractory acute graft-versus-host disease, backed by a recent $160 million financing that strengthens its commercial and clinical development efforts.

Mesoblast has secured FDA approval for Ryoncil®, the first mesenchymal stromal cell therapy for steroid-refractory acute graft versus host disease in children, while raising A$260 million to accelerate clinical trials and commercial rollout.

Botanix Pharmaceuticals has initiated the commercial rollout of Sofdra, its FDA-approved treatment for primary axillary hyperhidrosis, with first prescriptions dispensed and a fully trained sales force deployed. The company anticipates meaningful revenue growth starting in the first quarter of 2025, backed by strong payer contracts and a robust cash position.