FDA Clears Way for Faster Personalized Gene Editing Treatments

Gene-editing stocks rally on Bloomberg report that FDA plans to fast-track approval process

The news comes after Intellia disclosed on Monday that it’s pausing two late-stage CRISPR gene-editing trials because one patient was hospitalized with liver damage, which had sent the sector’s stocks sliding....

FDA Clears Way for Faster Personalized Gene Editing Treatments

A top US regulator plans to unveil a faster approach to approving custom gene-editing treatments, a move designed to unleash a wave of industry investment that will yield cures for patients with rare diseases.

FDA Clears Way For Faster Personalized Gene Editing Therapy

A top United States regulator plans to unveil a faster approach to approving custom gene-editing treatments, a move designed to unleash a wave of industry investment that will yield cures for patients with rare diseases. From a report: Vinay Prasad, who oversees gene therapies at the Food and Drug Administration, said scientific advances, like Crispr, have forced the agency to relax some of its strict rules. As an example, he cited the case of 1…

In Vivo Gene Editing for Rare Diseases Begins with Umbrella Clinical Trial

It’s been less than six months since the news of Baby KJ broke, a watershed moment for precision medicine with the first successful demonstration of a personalized in vivo gene-editing therapeutic. But for Becca Ahrens-Nicklas, MD, PhD, the physician who cared for KJ, and Kiran Musunuru, MD, PhD, the cardiologist and gene-editing researcher who designed the therapy, that single success was the requisite first domino to fall in the journey to dev…