BRIEF-Acelrx Pharmaceuticals Inc - FDA Determined That Review Of Niyad Eua Is Not A Priority And Has Therefore Declined To Issue An Eua For Niyad

Reuters

Sep 23, 2023

* ACELRX PHARMACEUTICALS INC - FDA DETERMINED THAT REVIEW OF NIYAD EUA IS NOT A PRIORITY AND HAS THEREFORE DECLINED TO ISSUE AN EUA FOR NIYAD

* ACELRX PHARMACEUTICALS INC - FDA ENCOURAGED CO TO CONTINUE TO ASSESS CLINICAL DEVELOPMENT OF THE NIYAD DEVICE

* ACELRX PHARMACEUTICALS INC - PLANS TO INITIATE REGISTRATIONAL STUDY OF NIYAD LATER THIS YEAR, ANTICIPATES SUBMITTING PMA FOR NIYAD TO THE FDA IN 2024

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