Posted by Michael Wonder on 23 Sep 2025
FDA issues complete response letter for apitegromab as a treatment for patients with spinal muscular atrophy
23 September 2025 - No other approvability issues cited in complete response letter.
Scholar Rock today announced that the US FDA has issued a complete response letter for the apitegromab biologics license application for the treatment of patients with spinal muscular atrophy.
