BTD

CEO Update: Denial of Breakthrough Therapy Designation

The US Food and Drug Administration (FDA) denied NRx Pharmaceuticals’ (NRx) request for Breakthrough Therapy Designation (BTD) for ZYESAMI® (aviptadil). BTD is not required for drug approval or emergency use authorization, but can afford faster review times, the ability to submit a rolling application, and dedicated FDA review personnel who may interact more frequently with […]

CEO Update: Breakthrough Therapy Designation

Recently, we’ve received several questions about the Breakthrough Therapy Designation (BTD) application NRx submitted to the US Food and Drug Administration (FDA) for ZYESAMI™ (aviptadil) last month. As you know, we received BTD for our psychiatry drug NRX-101 for suicidal bipolar depression. Admission to the BTD program provided us with increased access to review guidance […]