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).
Valneva is pushing forward with its live-attenuated, single-shot vaccine candidate, VLA1553, for chikungunya, a mosquito-borne viral disease for which there are no preventive vaccines or effective treatments available.
Samsung Biologics has introduced two new platforms focused on optimized antibody production and systematic screening of molecules at an early development stage.
The US FDA released new draft guidance yesterday discussing, among other challenges, how unresolved product quality issues might be addressed in the context of regulatory decision-making.
