The company is working with the U.S. regulator to move forward with an updated application, adding a decision is expected in the first half of 2026.

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TARRYTOWN, N.Y., April 18, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) ...