Biogen (NASDAQ:BIIB) reported that the U.S. FDA has declined to accept its request for a supplemental marketing authorization for a higher dose of Spinraza (nusinersen), a treatment for spinal ...
Ultragenyx Pharmaceutical has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) concerning its biologics licence application (BLA) for UX111 (ABO-102), an ...