FDA accepts PTC Therapeutics’ NDA for Sepiapterin, aiming for breakthrough in PKU treatment
PTC Therapeutics, Inc. has announced a significant step forward in its mission to combat phenylketonuria (PKU) by receiving FDA acceptance for the New Drug Application (NDA) of Sepiapterin. The acceptance of this NDA, supported by positive clinical trial results, brings much-needed hope to patients managing this rare metabolic disorder. The FDA’s action sets a critical […]