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- FDA approves Ultragenyx gene therapy for glycogen storage disorder; Overton faces confirmation hurdlesThe U.S. Food and Drug Administration has granted approval to Ultragenyx's gene therapy aimed at treating a glycogen storage disorder. This marks a regulatory milestone for the company and the rare…
- FDA rejects Osteal Therapeutics' combo therapy for joint-implant infectionsThe U.S. Food and Drug Administration rejected Osteal Therapeutics' lead combination therapy late last month. The agency cited concerns that prevented approval of the product intended to treat infe…