After the FDA’s first-ever public listening meeting on data-sharing in the cell and gene therapy space, new draft guidance aims to standardize the practice. But recent decisions call into question ...

The first gene therapies approved to treat sickle cell disease in December 2023 are struggling on the market. But there are glimpses of forward momentum as Vertex and Genetix Bio provide updates.

After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...

Ultragenyx said that the trial of the gene therapy will continue while data from the second primary endpoint is collected.

Successful program buildout prioritizes defined patient flow, infusion access, cold-chain capabilities, and accountability ...

On Wednesday, the U.S. Food and Drug Administration (FDA) published three new draft guidances that aim to offer greater clarity to sponsors of cell and gene therapies (CGTs) on issues related to ...

Forbes contributors publish independent expert analyses and insights. William A. Haseltine, Ph.D., covers genomics and regenerative medicine This voice experience is generated by AI. Learn more. This ...

In this webinar, Stefan Radtke will discuss the development of new high-throughput single-cell readouts for precise and comprehensive tracking of gene editing outcomes after autologous hematopoietic ...

Consider the case of patient WB, a 79-year-old male with recurrent diffuse large B cell lymphoma. He was referred for ...

A new method for safely inserting large chunks of DNA into genomes has now measured up in mice, potentially paving the way ...

The first cell rejuvenation therapy is set to enter clinics, testing if aging cells can be reset to a younger, healthier ...

The cell therapy manufacturing market offers significant opportunities driven by technological advancements, increasing clinical trials, and growing regulatory approvals. Key growth catalysts include ...