The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of five new products, among them a gene therapy for Wiskott‑Aldrich syndrome developed by Fondazione Telethon. The CHMP opinions mark critical regulatory steps toward EU market access for treatments spanning rare disease and specialty oncology indications. CHMP recommendations are based on dossiers demonstrating favorable benefit‑risk profiles and will move to the European Commission for final decisions. The inclusion of a charity‑sponsored gene therapy underscores alternative commercialization pathways when industry partners step away. If adopted by the Commission, approvals will reshape treatment options for orphan populations and validate pathways for non‑profit to industry handoffs in advanced therapies. Manufacturers and payers will closely watch labeling, post‑approval commitments, and access negotiations.