# A comprehensive analysis of CBER experience with AAV gene therapy IND submissions

Source: [nature.com](https://www.nature.com/articles/s41587-026-03378-9) · 2026-11-12 · Life
Page: https://themorning.science/story/a-comprehensive-analysis-of-cber-experience-with-aav-gene-therapy-ind-submission-6471675c53289f05
Kind: research · Impact: medium

## In brief

- An analysis of Investigational New Drug (IND) submissions to the US FDA from 1995 to 2025 examines CBER's experience with AAV gene therapy.
- The analysis reports rapid growth in adeno-associated virus (AAV) development.
- The study was published online in Nature Biotechnology on 12 November 2026.

## Why it matters

The analysis offers a data-based view of how AAV gene therapy programmes have moved through FDA IND submissions over three decades, which is useful context for researchers planning or assessing gene therapy trials.

## Timeline

- 2026-11-12: Analysis published online in Nature Biotechnology

## Coverage

- [A comprehensive analysis of CBER experience with AAV gene therapy IND submissions](https://www.nature.com/articles/s41587-026-03378-9) — nature.com, 2026-11-12

Tags: gene-therapy, aav, fda, regulation, clinical-trials

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Brief generated by AI (claude-haiku-5-5) from the reporting listed under Coverage. Headlines belong to their publishers. The Morning Science – https://themorning.science