Judgment of the General Court (Fifth Chamber, Extended Composition) of 24 September 2025.#Sanofi BV, anciennement Genzyme Europe BV v European Commission.#Public health – Medicinal products for human use – Marketing authorisation for the medicinal product Nexviadyme (avalglucosidase alfa) – Non-recognition of avalglucosidase alfa as a new active substance – Directive 2001/83/EC – Regulation (EC) No 726/2004 – Commission document ‘Notice to Applicants, Volume 2A, Procedures for marketing authorisation, Chapter 1, Marketing Authorisation’ – Standard of proof – Obligation to state reasons – Principle of good administration – Right to be heard – Decision to remove the medicinal product from the European Union Register of Orphan Medicinal Products – Regulation (EC) No 141/2000 – Regulation (EC) No 847/2000 – Significant benefit – Standard of proof – Obligation to state reasons.#Case T-483/22.