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- FDA issues complete response letter rejecting ITM’s neuroendocrine tumor drug over manufacturing concernsThe U.S. Food and Drug Administration sent a complete response letter to ITM Isotopes Technologies, refusing approval of its lead candidate for gastroenteropancreatic neuroendocrine tumors because…
- Scholar Rock removes Novo Nordisk's Catalent plant from FDA filing for SMA drug apitegromabScholar Rock announced it will no longer list Novo Nordisk’s legacy Catalent facility as a contract manufacturer in its FDA resubmission for apitegromab, its spinal muscular atrophy (SMA) candidate…