Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announced that on January 5, 2023, the U.S. Food and Drug Administration (FDA) notified the Company that based on manufacturing information submitted to the Agency on December 20, 2022, in response to an information request, the PDUFA date has been revised to May 19, 2023, and proposed labeling discussions to no later than April 20, 2023.
January 9, 2023
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