FDA unveils rules for bespoke gene therapies, predicting flood of rare disease applications - statnews.com
business 2026/02/23 20:49:13

FDA unveils rules for bespoke gene therapies, predicting flood of rare disease applications - statnews.com

Source:STAT
Author:Jason Mast, Lizzy Lawrence

The FDA expects a flood of applications for a new “plausible mechanism pathway” for approval of bespoke gene-editing treatments.