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FDA Rejects Ultragenyx’s Gene Therapy for Rare Disease, Citing Manufacturing Concerns – Patient Worthy
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FDA Rejects Ultragenyx’s Gene Therapy for Rare Disease, Citing Manufacturing Concerns – Patient Worthy
Ultragenyx Pharmaceutical, a biotechnology company developing treatments for rare diseases, has received a setback from the U.S. Food and Drug Administration (FDA) regarding its gene therapy candidate, DTX401. According to BioPharma Dive, the therapy, designed for patients with glycogen storage disease type Ia (GSDIa), was rejected by the FDA, which issued a complete response letter […]
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