The U.S. Food and Drug Administration (FDA) has granted Celcuity’s drug Gedatolisib Priority Review designation for its New Drug Application (NDA).

老虎证券2026/06/02 12:21

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According to documents submitted to the U.S. Securities and Exchange Commission (SEC), the Prescription Drug User Fee Act (PDUFA) target date for the application has been set for July 17, 2026. This marks a key step in the drug's regulatory approval process and is expected to accelerate its path to market.

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The U.S. Food and Drug Administration (FDA) has granted Celcuity’s drug Gedatolisib Priority Review designation for its New Drug Application (NDA).

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