ARTICLE | Clinical News
Nusinersen regulatory update
November 4, 2016 5:36 PM UTC
Biogen said FDA accepted an NDA and EMA accepted an MAA for nusinersen to treat spinal muscular atrophy (SMA). FDA granted Priority Review to the NDA; Biogen declined to disclose the PDUFA date. EMA’s CHMP has granted the product accelerated assessment. Biogen said it plans to market nusinersen under the brand name Spinraza, which FDA and CHMP have conditionally accepted...
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