BioCryst submits new drug application to FDA

BioCryst Pharmaceuticals, Inc. has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of oral, once daily berotralstat (BCX7353) for the prevention of HAE attacks. “HAE patients are waiting for a safe, effective oral therapy to manage their disease and this NDA submission brings berotralstat an important step … Continue reading BioCryst submits new drug application to FDA