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Orphalan announces European Medicines Agency (EMA) acceptance for review of Marketing Authorization Application (MAA) for KIZFIZO® Company News

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 London, UK, March 30, 2026 – Orphalan, a pharmaceutical company dedicated to the…
March 30, 2026
Rare disease Run Company News

Rare disease Run

On #InternationalRareDiseaseDay 2026, we join the global movement to recognise 300 million people worldwide living with a rare disease. At Orphalan, our mission is clear: to develop and deliver treatments for…
March 16, 2026
Orphalan, a global pharmaceutical company specializing in the development and commercialization of orphan drugs, announces the acquisition of Orphelia Pharma, a French pharmaceutical company dedicated to rare and serious pediatric diseases in neurology and oncology. Press Release

Orphalan, a global pharmaceutical company specializing in the development and commercialization of orphan drugs, announces the acquisition of Orphelia Pharma, a French pharmaceutical company dedicated to rare and serious pediatric diseases in neurology and oncology.

This strategic transaction further strengthens Orphalan’s position as a European leader with a global commercial footprint in rare diseases and expands our therapeutic portfolio. Paris, December 1, 2025 – Orphalan,…
November 27, 2025
Orphalan Partners with MAP International and the Wilson Disease Association to Provide Life-Changing Medicine to Underserved Communities Press Release

Orphalan Partners with MAP International and the Wilson Disease Association to Provide Life-Changing Medicine to Underserved Communities

Paris, France —27, June, 2025— Orphalan SA, a global pharmaceutical company focused on rare diseases, is partnering with MAP International and the Wilson Disease Association (WDA) to provide Cuvrior® (trientine…
June 27, 2025
Orphalan announces China NMPA’s approval of its trientine tetrahydrochloride product for the treatment of Wilson disease Company NewsPress Release

Orphalan announces China NMPA’s approval of its trientine tetrahydrochloride product for the treatment of Wilson disease

Paris, France 18 January, 2024 – Orphalan SA (“Orphalan” or “the Company”), an international orphan drug development and commercialization company, today announces the approval of its trientine tetrahydrochloride product by China’s…
January 18, 2024
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 Press Release

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

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. Paris, France 2 May 2022 – Orphalan…
May 2, 2022
FDA acceptance for filing of New Drug Application (NDA) for trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson’s Disease Press Release

FDA acceptance for filing of New Drug Application (NDA) for trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson’s Disease

Orphalan announces FDA acceptance for filing of New Drug Application (NDA) for trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson’s Disease —NDA supported by positive data from Phase 3…
September 2, 2021