The regulator informed bluebird bio that it will not convene an advisory committee meeting to discuss the company’s application for the gene therapy being developed for sickle cell disease.
Tag Archive for: lovo-cel
Bluebird bio Inc. said on Monday it has submitted a marketing application to the U.S. Food and Drug Administration for its gene therapy to treat sickle cell disease.
In an earnings call, bluebird bio revealed it is unlikely to meet its first-quarter goal to submit a Biologics License Application for sickle cell disease (SCD) gene therapy lovo-cel.
