After delaying a June PDUFA date, the U.S. FDA has approved Kalvista Pharmaceuticals Inc.’s Ekterly (sebetralstat) for hereditary angioedema (HAE) in those aged 12 and older. The plasma kallikrein ...

Ekterly comes in the form of a 300 mg tablet. The recommended dosage is 600 mg split into two doses taken at the earliest sign of an attack, according to the prescribing information. Additional ...

The Food and Drug Administration (FDA) has approved Ekterly ® (sebetralstat) for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.

The company had blamed FDA "resource constraints" for the delay, while a rival drug for hereditary angioedema received an ...

For the second time in under 3 weeks, the FDA has approved treatment for the inherited genetic disorder characterized by ...

The US Food and Drug Administration (FDA) has approved KalVista Pharmaceuticals' Ekterly (sebetralstat) as the first and only ...

KalVista Pharmaceuticals, Inc. (NASDAQ:KALV) saw its stock soar by 19% after receiving FDA approval for EKTERLY (sebetralstat ...

Ekterly’s road to approval was not a smooth one. Last month, the FDA informed KalVista it would not meet its PDUFA date due ...