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 ...

KalVista Pharmaceuticals said on Monday the U.S. Food and Drug Administration has approved its drug, Ekterly, for a type of ...

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

After facing an unexpected regulatory delay last month, KalVista Pharmaceuticals has leapt into the commercial realm with the ...

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

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.

Under the new leadership of Marty Makary, the FDA should focus more attention on the critical role of real-world clinical data — such as from health insurance databases — in the ongoing assessment of ...

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 ...

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

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 ...