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

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 provided an operational update and released financial results for the fiscal year ended April 30, 2025.

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 ...

Ekterly becomes the first FDA-approved oral on-demand treatment for hereditary angioedema in 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 ...

Moderna (MRNA), an undervalued name in the biotech space, rose to prominence during the COVID-19 pandemic. This occurred when ...

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.

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

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 ...

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