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The US Food and Drug Administration (FDA) has approved KalVista Pharmaceuticals' Ekterly (sebetralstat) as the first and only ...
KalVista Pharmaceuticals, Inc. (KALV) on Monday said that the U.S. Food and Drug Administration (FDA) has approved its drug ...
KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the U.S. Food and Drug Administration (FDA) has approved EKTERLY® (sebetralstat), a novel ...
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.
FDA approval of EKTERLY makes KalVista Pharmaceuticals, Inc. the first to offer an oral on-demand HAE therapy. Click here to find out why KALV is a Strong Buy.
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 FDA has approved Ekterly, the first oral treatment for hereditary angioedema. With the approval, the drug is now cleared for treatment in adults and children ages 12 and older.
Ekterly becomes the first FDA-approved oral on-demand treatment for hereditary angioedema in patients aged 12 years and older ...
The US Food and Drug Administration (FDA) has approved KalVista Pharmaceuticals' Ekterly (sebetralstat) as the first and only oral on-demand medication for acute attacks of hereditary angioedema ...
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 ...