Today, Biogen announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its supplemental New Drug Application for a high-dose regimen of nusinersen in the treatment of SMA.
Today, Scholar Rock announced that the U.S. Food and Drug Administration (FDA) has delayed approval of the Biologics License Application (BLA) for apitegromab in the treatment of people living with SMA.
We are pleased to share a community letter Biogen, announcing topline results from the Phase 1 study of salanersen (BIIB115) for SMA.
We are pleased to share a community letter from Roche, announcing that the European Commission (EC) has approved a new, room- temperature stable tablet formulation of risdiplam.