apitegromab

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Scholar Rock gets first drug approval as FDA okays Isembyld

Scholar Rock has won its first product approval, on its second attempt, as the FDA gives a green light to its spinal muscular atrophy drug Isembyld.

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David Hallal, Scholar Rock's chairman and chief executive

Manufacturing issues block FDA nod for Scholar Rock SMA drug

Unresolved issues at a manufacturing plant operated by Novo Nordisk have led to a complete response letter for Scholar Rock's SMA drug apitegromab.

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Scholar Rock preps filings after SMA antibody clears trial

Shares in Scholar Rock have gone into overdrive after the biotech reported positive phase 3 results with apitegromab in patients with spinal muscular atrophy (SMA), setting up regulatory fi

Scholar Rock gets first drug approval as FDA okays Isembyld

Manufacturing issues block FDA nod for Scholar Rock SMA drug

Scholar Rock preps filings after SMA antibody clears trial

Iambic prices its IPO, seeking to raise up to $160m

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