Latest Fda Approvals News

Clarity Pharmaceuticals has initiated its second registrational Phase III AMPLIFY trial for the Cu-SAR-bisPSMA PET imaging agent targeting biochemical recurrence of prostate cancer. The multi-centre study aims to generate critical data supporting FDA approval and could redefine prostate cancer diagnostics.

Cynata Therapeutics confirms that the recent FDA orphan-drug exclusivity granted to Ryoncil® will not block approval of its CYP-001 therapy, highlighting key differences in drug composition and patient indications.

Mesoblast has been granted a seven-year orphan-drug exclusivity by the FDA for its cell therapy Ryoncil, reinforcing its market position in treating steroid-refractory acute graft versus host disease in children.

EBR Systems has won FDA approval for its pioneering leadless WiSE CRT System, setting the stage for a phased US commercial rollout. The company also secured key Medicare reimbursement pathways and expanded manufacturing capacity, though financial sustainability remains a concern.

Anteris Technologies has submitted its FDA Investigational Device Exemption for the pivotal PARADIGM Trial of its DurAVR heart valve and marked a milestone of 100 patients treated, while expanding manufacturing capacity amid rising R&D costs.

Anteris Technologies Global Corp. reported a $21.9 million net loss for Q1 2025, driven by increased R&D spending as it scales manufacturing and prepares pivotal trials for its DurAVR Transcatheter Heart Valve. The company’s recent $80 million IPO proceeds are being deployed to support these efforts and repay debt.

Botanix Pharmaceuticals clarifies its lead product Sofdra is unlikely to face price cuts under the proposed US executive order on drug pricing, citing its exclusive US market approval and distinct formulations abroad.

Cleo Diagnostics has completed alpha testing of its ovarian cancer pre-surgical triage assay kits, confirming robust performance and differentiation between benign and malignant disease. The company now moves forward to assay optimisation and manufacturing scale-up, edging closer to FDA submission and commercial launch.

Universal Biosensors reports a 6% sales increase in Q1 2025, driven by strong growth in wine and veterinary biosensors, while preparing to launch its innovative water testing product later this year.

Acrux Limited, partnering with TruPharma, has introduced its Dapsone 7.5% Gel in the US, featuring a unique tube packaging that aims to improve patient convenience and reduce environmental impact.

AVITA Medical reported a strong first quarter with revenues up 67% to $18.5 million, driven by expanded commercial sales and new product introductions. Despite a narrower net loss, the company faces ongoing challenges from revenue covenants and macroeconomic pressures.

Echo IQ has raised $17.3 million through a strongly supported institutional placement to fund US commercialization and FDA approval efforts for its EchoSolv AI cardiology products.