The attack data in RAPIDe-3 have continued to accrue following the achievement of target enrollment in the study; we now estimate that our RAPIDe-3 topline data announcement will be in the fourth ...

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

KalVista Pharmaceuticals, Inc. (Nasdaq: KALV), today provided an operational update and released financial results for the fiscal year ended April 30, 2025.

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 said on Monday the U.S. Food and Drug Administration has approved its drug, the first on-demand oral ...

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

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

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.

Hereditary angioedema (HAE) is a genetic disorder that causes sudden episodes of swelling, often accompanied by abdominal pain. Affecting roughly 1 in 50 000 people, HAE typically appears in childhood ...

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