Bluebird gene therapy wins FDA’s ‘breakthrough’ designation

February 2, 2015 3:13 PM

13 0

Cambridge startup Bluebird Bio Inc., which is working in the field of gene therapy, said Monday that its experimental treatment for a rare blood disorder has won a “breakthrough therapy” designation from the Food and Drug Administration.

The designation was created by the FDA to speed up the development and regulatory review of drug candidates that treat serious or life-threatening diseases when early clinical studies show substantial improvement over existing medicines.

Read more

To category page