Application is supported by results from the DEVOTE study, which suggested that two doses of Spinraza (nusinerse) 50 mg taken ...
BIIB's regulatory filings are supported by late-stage data, which show that treatment with a higher Spinraza dose improves motor function in infants with SMA.
Biogen’s applications for the higher dose regimen of SMA drug Spinraza are now under review in the US and Europe.
Regulators in the U.S. and the European Union agreed to review Biogen’s applications for approval of a higher dose Spinraza ...
Last year, the first phase 3 trial of Sage Therapeutics and Biogen's antidepressant hopeful zuranolone hit its efficacy targets, but raised doubts about the durability of the response. Now ...
Biogen’s Spinraza (nusinersen) is another pricey option already on the market requiring injections every four months, and Roche plans a European filing of its potential rival risdiplam this year.