bluebird bio started last week on tenterhooks, as FDA advisors cast their eyes over data for two gene therapy candidates that are key to its future as a commercially viable concern.
The FDA may have safety concerns abut bluebird bio's gene therapy for rare, fatal disease cerebral adrenoleukodystrophy (CALD), but its advisors believe its benefits far outweigh the risks.
Around 425,000 people in England and Wales with cardiovascular disease who are at risk of a secondary stroke or heart attack, could be eligible for treatment with Amarin's Vazkepa, followin
Roche has secured its first regulatory approval for mosunetuzumab, a first-in-class CD20xCD3 bispecific antibody, as a treatment for patients with follicular lymphoma (FL) in the EU.