FDA illuminates new approval pathway for bespoke gene editing therapies

After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled | 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teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, like the one that treated critically ill baby KJ last year, formally embraced by the agency.