When was Qalsody approved by the FDA?

The U.S. Food and Drug Administration (FDA) approved Qalsody in May 2023 for the treatment of adults with amyotrophic lateral sclerosis (ALS) associated with mutations in the SOD1 gene. The decision, marking the first conditional approval of an ALS treatment in the U.S., was granted under the agency’s accelerated approval pathway. Continuous approval of Qalsody may be contingent on confirmation of its clinical benefits in ongoing clinical trials.