This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. The Food and Drug Administration on Monday approved a ...
Long-term data from DEVOTE/ONWARD studies show benefits of high dose nusinersen in people living with spinal muscular atrophy (SMA) New Phase 1b data further illustrate potential of salanersen in SMA, ...
The US Food and Drug Administration (FDA) has rejected Biogen’s high-dose Spinraza (nusinersen) for the treatment of spinal muscular atrophy (SMA). The agency chose to decline the antisense ...
Add Yahoo as a preferred source to see more of our stories on Google. Breakthrough drugs like Zolgensma and other gene therapies are adding to the nation’s ballooning bill for prescription drugs, ...
Within a week of Christmas day, a drug called nusinersen will be in the hands of doctors across the nation, who will use it, most urgently, to treat young children with a severe and potentially fatal ...
Biogen BIIB announced that the FDA has issued a complete response letter (CRL) to its supplemental new drug application (sNDA) seeking label expansion for a higher dose of its renowned spinal muscular ...