Diamyd Medical today announced a positive in-person Type C meeting with the U.S. Food and Drug Administration (FDA), where alignment was achieved on key components of the planned early readout and an ...
Company to conduct a Phase II multi-regional clinical trial (MRCT) for the treatment of Ulcerative Colitis (UC) A Phase Ib Study of AC-101 for Ulcerative Colitis (UC) has been initiated in China ...
U.S. Food and Drug Administration (FDA) agrees that data from ongoing Phase I/II studies compared to a natural history external control may serve as the primary basis for a Biologics License ...