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BIIB's next-gen SMA therapy Salanersen wins FDA's breakthrough tag
Biogen BIIB recently announced that the FDA has granted Breakthrough Therapy designation to Salanersen, an investigational ...
In early June 2026, Biogen reported that the FDA granted Breakthrough Therapy Designation to its investigational SMA treatment salanersen, while also, alongside UCB, presenting additional positive ...
Salanersen, which is designed for once-yearly dosing, is a potential successor to Biogen's blockbuster SMA drug Spinraza, which generated worldwide sales of nearly $1.55 billion last year and requires ...
Phase 2 trial results showed an improvement in MASH with no worsening of fibrosis in all treatment groups compared with placebo. The Food and Drug Administration (FDA) has granted Breakthrough Therapy ...
Alixorexton at all doses demonstrated significant improvements from baseline in mean sleep latency compared with placebo. The Food and Drug Administration (FDA) has granted Breakthrough Therapy ...
A single jab of a breakthrough gene therapy could reverse hearing loss in people within weeks, according to new research. The cutting-edge therapy improved hearing in children and adults with ...
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