This Week’s Biopharma News: New Pharma Legislation in Europe
December 16, 2025
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6 min
A landmark agreement on a major reform of EU pharmaceutical legislation has been reached, marking the most significant update in over 20 years. This new legislation aims to modernize the development, authorization, and monitoring of medicines, emphasizing digitalization and expedited processes to address public health challenges such as antimicrobial resistance. In parallel, FDA has approved the gene therapy Waskyra for Wiskott–Aldrich syndrome, marking a breakthrough in treatment options. Additional news includes Moderna's licensing deal for Nanexa’s drug delivery technology and advancements in cellular therapy manufacturing.
1. EU pharmaceutical legislation reform aims to modernize processes and enhance access. 2. Waskyra is the first FDA-approved gene therapy for Wiskott–Aldrich syndrome. 3. Moderna licenses drug delivery technology from Nanexa. 4. Uplizna approved for generalized myasthenia gravis treatment. 5. Patient remains disease-free five years post CAR T cell therapy.
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