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 ...
Novartis is on the final straight to approval of its spinal muscular atrophy (SMA) gene therapy Zolgensma in the EU, after getting a recommendation for approval from the CHMP. The positive opinion ...
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