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Investing.com -- Ultragenyx Pharmaceutical (TADAWUL: 2070) Inc. (NASDAQ: RARE) stock fell over 5% after the company announced that the U.S. Food and Drug Administration (FDA) has issued a Complete ...
Ultragenyx Pharmaceutical said federal regulators have issued a complete response letter to its application for a metabolic disorder treatment that may delay the potential approval to 2026.
Complete Response Letter (CRL) cited specific chemistry, manufacturing and controls (CMC) related observations that are ...