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Biologics articles

FDA comparability guidance: The impact of cell and gene therapy products

2025-07-11T10:26:00+01:00By Hao Liu, Laura Guijarro, Rajenda Kunda and Slobodanka Cirin-Varadjan

Recent advances and the near-term outlook for Advanced Therapy Medicinal Products in cancer treatment
2025-05-02T13:41:00+01:00
Advanced therapies: A maturing regulatory framework
2025-05-02T13:40:00+01:00
Gene Therapy Medicinal Products: An examination of regulatory CMC requirements
2025-05-01T09:43:00+01:00
Considerations for generics developers moving into the field of biosimilars
2025-01-10T08:49:00+00:00
Small interfering RNA: regulatory challenges and therapeutic potential
2024-10-11T10:25:00+01:00
Introduction to cannabinoids: understanding UK regulation, structure, industry dynamics and charting the future
2024-09-13T12:16:00+01:00

Botanicals and digestive enzymes demonstrate the complexity and diversity of food supplement regulations in the European Union
2024-09-13T12:14:00+01:00
Cell gene therapy: clinical trial application procedure of CAR-T therapy in the EU
2024-05-08T10:30:00+01:00
The first approval of a CRISPR-Cas9 gene editing medicinal product in the European Union: Casgevy
2024-05-08T10:30:00+01:00
Near-term challenges of advanced therapy medicinal products: a maturing product class
2024-05-08T10:00:00+01:00
Dr Peter Marks on reflecting innovation through FDA regulation
2024-05-08T08:30:00+01:00
The increasing complexity of biological medicinal products
2024-01-05T00:05:00+00:00