reuters.com

Scholar Rock withdraws Europe drug filing and plans resubmission

Scholar Rock Holding logoScholar Rock Holding
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Scholar Rock withdrew its European application for its experimental spinal muscular atrophy drug and will resubmit using a different manufacturing site after problems identified at a Novo Nordisk-owned facility. The company had also faced an earlier FDA rejection for apitegromab linked to manufacturing issues found during an inspection of a Bloomington, Indiana plant.

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