Sunday, 22 July 2018 - 3:46
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Spinal muscular atrophy

SMA, FDA and EMA accept applications for Biogen’ s nusinersen

Biogen today announced that its (New Drug Application) for nusinersen, an investigational treatment for SMA (spinal muscular atrophy) has been accepted by FDA for Priority Review. At the same time, the MAA (Marketing Authorization Application) for the same product…

SMA, PTC Therapeutics and partner Roche initiate Phase II for RG7916

PTC Therapeutics announced that its joint development program in SMA (Spinal Muscular Atrophy), in partnership with Roche and in collaboration with the SMA Foundation (SMAF) initiated Phase II. Specifically, the study named SUNFISH, investigating the safety, tolerability and efficacy of…

Nusinersen, Biogen completes application to FDA

Biogen and Ionis today announced that Biogen has completed the NDA to FDA for nusinersen, an investigational treatment for spinal muscular atrophy (SMA). Biogen has also applied for Priority Review. In addition to the NDA submitted to FDA, Biogen plans…