
Orphalan announces European Medicines Agency (EMA) acceptance for review of Marketing Authorization Application (MAA) for KIZFIZO®
Marketing Authorization Application for KIZFIZO® accepted for review by the EMA for the treatment of malignant glioma.
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Marketing Authorization Application for KIZFIZO® accepted for review by the EMA for the treatment of malignant glioma.

Marketing Authorization Application for KIZFIZO® accepted for review by the EMA for the treatment of malignant glioma.

On International Rare Disease Day 2026, Orphalan joins the global movement with 43 colleagues across Europe, China, and the U.S. running for rare.

Strategic acquisition strengthens Orphalan’s position in rare disease therapeutics and expands portfolio capabilities.

Orphalan SA partners with MAP International and the Wilson Disease Association to donate Cuvrior® to patients with Wilson Disease in developing countries.

Strategic partnership with Kyuan Xinhai (Beijing) Medical Products Trade Co., Ltd to transform access to Wilson’s disease treatment for Chinese patients.

China’s National Medical Products Administration approves Orphalan’s trientine tetrahydrochloride product – the first trientine approved by the NMPA – for the treatment of Wilson disease.

Over the years, I have been deeply moved by the stories of many patients, but one particularly stands out.

Our CEO Naseem Amin authors an insightful article for Life Science Leader on why we should care about rare disease research.

Cuvrior™ now available in the US for the treatment of adult patients with stable Wilson disease who are de-coppered and tolerant to penicillamine.

Orphalan CEO Naseem Amin sits down with DNA Today host Kira Dineen to discuss Wilson’s Disease and the potential advancements in its treatments.

Trial supported Orphalan’s successful application to the FDA for approval of Cuvrior™ (trientine tetrahydrochloride) for Wilson’s disease.

World’s first global Wilson’s Registry will provide an international platform for sharing real-world information about Wilson’s disease.

Dr. Naseem Amin, Chief Executive Officer at Orphalan, discusses the announcement of the FDA approval of Cuvrior™.

Orphalan announces FDA approval of Cuvrior™ for the treatment of adult patients with stable Wilson’s disease who are de-coppered and tolerant to penicillamine.

A Q&A between Omar Kamlin, Senior Medical Director at Orphalan SA, and Prof. Pramod Mistry, Director of Yale Lysosomal Disease Center, to mark World Rare Disease Day 2022.

Orphalan SA today announces two new appointments to the management team: Tim Jenkins as Chief Development Officer and Chris Homan as Chief Quality Officer.

NDA supported by positive data from Phase 3 CHELATE clinical trial. TETA 4-HCl previously granted Orphan Drug Designation for first-line treatment of Wilson’s Disease.

Prof. Michael Schilsky of Yale University presents top-line results from Orphalan’s CHELATE Phase 3 trial at EASL’s International Liver Congress 2021.

Positive top-line data announced from our Phase 3 head-to-head trial of trientine tetrahydrochloride and d-penicillamine at EASL’s International Liver Congress 2021.

CHELATE trial confirmed trientine tetrahydrochloride was non-inferior to d-Penicillamine as maintenance therapy for Wilson’s Disease, with a markedly superior tolerability profile.
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