Food and Drug Administration (FDA)

The U.S. Food and Drug Administration (FDA) on Tuesday accepted and granted Priority Review designation to Apellis Pharmaceuticals, Inc.’s (NASDAQ:APLS) supplemental New Drug Application (sNDA) for Empaveli (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex...

The U.S. Food and Drug Administration (FDA) has offered positive feedback to CaaMTech, Inc. on its CT-4201 psilocin prodrug program, specifically endorsing the company's approach to addressing "functional unblinding" in its drug trials. This regulatory milestone not only clears the clinical...

In a recent announcement, 23andMe Holding Co. (NASDAQ:ME) has disclosed that the U.S. Food and Drug Administration (FDA) has given the green light to its investigational new drug application for 23ME-01473 (‘1473), a natural killer (NK) cell activator designed to combat cancer. What Happened...