The FDA has approved garadacimab-gxii for prophylactic use in patients aged 12 years and older with hereditary angioedema, ...

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

Ekterly becomes the first FDA-approved oral on-demand treatment for hereditary angioedema in patients aged 12 years and older ...

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

KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the U.S. Food and Drug Administration (FDA) has approved ...

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

KalVista Pharma has finally received FDA approval for its oral kallikrein inhibitor sebetralstat, becoming the first ...

KalVista Pharmaceuticals shares jumped in premarket trading Monday after the company said it has received regulatory approval for its treatment of hereditary angioedema. Shares traded 20% higher ahead ...

Received FDA approval of EKTERLY® (sebetralstat)-the first and only oral on-demand treatment for hereditary angioedema; U.S. launch underway - - Six additional global regulatory submissions under ...

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.