The US FDA could approve as many new gene therapies in 2023 as it has in the previous five years. Development in the field has rapidly accelerated, but still faces hurdles.

The US FDA could approve as many new gene therapies in 2023 as it has in the previous five years. Development in the field has rapidly accelerated, but still faces hurdles.

A few years ago, investors were calling on Vertex to buy in late-stage innovation, but its focus on audacious drug development goals looks set to pay off with a groundbreaking CRISPR-based sickle cell disease cell therapy approaching the market. Its R&D head David Altshuler talked to Scrip about its approach.

Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a recent analysis of FDA approval decisions since 2021.