bluebird bio has announced the submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for lovotibeglogene autotemcel (lovo-cel) gene therapy in patients with sickle cell disease (SCD).
The US Food and Drug Administration (FDA) has granted Accelerated Approval for bluebird bio’s Skysona (elivaldogene autotemcel), also known as eli-cel, to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral...
The U.S. Food and Drug Administration (FDA) has approved bluebird bio’s Zynteglo (betibeglogene autotemcel), also known as beti-cel: a one-time gene therapy custom-designed to treat the underlying genetic cause of beta thalassemia in adult and pediatric...
Microbiome-focused company, Kaleido Biosciences, in a filing with the US Securities and Exchange Commission (SEC) on Friday, announced its intention to cease all company operations, lay off its remaining staff and delist from the Nasdaq Exchange.
Japan’s ministry for health has approved Abecma as a CAR T-cell therapy for adults with relapsed or refractory multiple myeloma who received at least three prior therapies.
bluebird bio has signed a long-term lease for a 61,000 square foot facility at Assembly Row, Greater Boston: saying the new headquarters has been designed to reflect modern ways of working and deliver significant cost savings.
Novo Nordisk partners with bluebird on a three-year research arrangement looking to discover gene therapy candidates for the treatment of genetic diseases, including hemophilia.
The Alliance for Regenerative Medicine released a ‘Statement of Principles’ on gene editing, as controversy over the technology’s potential rumbles on.
Bluebird has received EU conditional marketing approval for patients with transfusion-dependent β-thalassemia, becoming the first treatment from its pipeline to receive approval.
Bluebird bio opens its first wholly owned manufacturing facility to produce lentiviral vectors for the company’s investigational gene and cell therapies.
With nearly 300 cell and gene therapies in development, targeting more than 100 diseases, 2019 could be set to be a big year for cell and gene therapies.
