After a partial clinical hold caused bluebird to miss its own first-quarter FDA filing goal, the company says its sickle cell disease gene therapy application is in.

New Drug Application for Oxbryta dispersible tablets also accepted for priority review Approximately 17,000 children ages 4 to 11 years have sickle cell disease in the United States SOUTH SAN ...

The FDA also approved GBT’s separate New Drug Application (NDA) for Oxbryta (voxelotor) tablets for oral suspension, a new dispersible, once-daily tablet dosage form suitable for patients ages 4 ...

bluebird bio Announces FDA Priority Review of the Biologics License Application for lovotibeglogene autotemcel (lovo-cel) for Patients with Sickle Cell Disease (SCD) 12 years and Older with a ...