Unresolved compliance issues at a manufacturing plant operated by Novo Nordisk have led to a complete response letter for Scholar Rock's lead drug for spinal muscular atrophy (SMA). The CRL is related ...
A big part of Biogen's efforts to defend its spinal muscular atrophy (SMA) business has been dealt a setback by the FDA, which declined to approve a high-dose version of its flagship Spinraza product.
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