Key trends include strategic CDMO partnerships and a shift to in vivo administration, enhancing accessibility and innovation ...

Regulatory authorities emphasize integrated control strategies, but CAR-T specification setting requires balancing data rigor with regulatory flexibility.

Universal gene‑edited CAR‑T therapies turn donor T cells into off‑the‑shelf cancer treatments, cutting delays and costs while ...

NHS Scotland has approved a one-time CRISPR gene therapy for severe sickle cell disease, offering durable reduction in vaso-occlusive crises for eligible patients.

Reducing manual touchpoints is an important part of supporting more consistent and scalable manufacturing processes.

Fred Hutchinson researchers are testing a simple idea with surprisingly big potential: a special type of foam that makes gene therapy more efficient.

A "gene silencer" (technically known as small interfering RNA, or siRNA), locally delivered by nanoparticles embedded in an ...

The cell and gene therapy sector has never lacked attention, but all too often, the narrative swings from one extreme to ...

AskBio Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, recently announced that the United States Food and Drug Administration (FDA) has ...

"Regulatory flexibility must be tailored for cell and gene therapies," commented FDA Commissioner Marty Makary. "These are ...

Serenity Cole enjoyed Christmas last month relaxing with her family near her St. Louis home, making crafts and visiting friends. It was a contrast to how Cole, 18, spent part of the 2024 holiday ...

The procedure aims to extend the lifespan of blood vessels used during the graft process in the surgery.