Biogen Stock Pops After FDA Approves Drug For Spinal Muscular Atrophy - Biogen (NASDAQ:BIIB)
The high-dose SPINRAZA regimen showed significant motor function improvements in infants with spinal muscular atrophy, based on Phase 2/3 DEVOTE study data, FDA said.
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FDA Approves New High Dose Regimen of SPINRAZA® (nusinersen) for Spinal Muscular Atrophy
The approval was anchored on data from the pivotal DEVOTE study that investigated the efficacy and safety of the High Dose Regimen of SPINRAZA in treatment-naïve and previously treated SPINRAZA patientsHigh Dose SPINRAZA will be available in the United States…
US FDA approves higher dose of Biogen’s genetic disorder drug - Regional Media News
March 30 (Reuters) - The U.S. Food and Drug Administration has approved a higher-dose version of Biogen's drug for a rare genetic disorder that causes progressive muscle weakness, the company said on Monday, offering patients a potentially more effective option. The regulator had declined to approve the company's application last year, seeking updated technical information. The therapy, Spinraza, is approved in the U.S. for spinal muscular atrop…
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