FDA Rejects New Drug Application for Edsivo, Says Additional Trial Is Needed
Acer Therapeutics has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application for Edsivo (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS), the company announced. In the letter, the FDA requested additional data from “an adequate and well-controlled…