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PharmExec9h
FDA Approves KalVista Pharmaceuticals’ Ekterly for Hereditary Angioedema
Ekterly becomes the first FDA-approved oral on-demand treatment for hereditary angioedema in patients aged 12 years and older ...
KalVista: FDA Approval Of EKTERLY As Oral On-Demand HAE Drug Is Just Beginning
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.
MPR5h
FDA Approves Oral Ekterly for On-Demand Hereditary Angioedema Treatment
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.
BioPharma Dive1d
After delay, Kalvista wins FDA OK for drug to treat rare swelling disorder
The company had blamed FDA "resource constraints" for the delay, while a rival drug for hereditary angioedema received an ...
Business Wire1d
KalVista Pharmaceuticals Announces FDA Approval of EKTERLY® (sebetralstat), First and Only Oral On-demand Treatment for Hereditary Angioedema
KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the U.S. Food and Drug Administration (FDA) has approved EKTERLY® (sebetralstat), a novel ...
US FDA approves KalVista Pharma's swelling disorder drug, shares rise
KalVista Pharmaceuticals said on Monday the U.S. Food and Drug Administration has approved its drug, Ekterly, for a type of ...
BioSpace1d
KalVista Wins OK for First On-Demand Hereditary Angioedema Pill
Ekterly’s road to approval was not a smooth one. Last month, the FDA informed KalVista it would not meet its PDUFA date due ...
Fierce Pharma1d
KalVista bounces back from FDA delay with approval for oral rare disease med Ekterly
After facing an unexpected regulatory delay last month, KalVista Pharmaceuticals has leapt into the commercial realm with the ...
pharmaphorum1d
KalVista bags FDA approval for delayed oral HAE drug
KalVista Pharma has finally received FDA approval for its oral kallikrein inhibitor sebetralstat, becoming the first ...
Pharmaceutical Technology on MSN1d
FDA approves KalVista’s Ekterly for hereditary angioedema
The US Food and Drug Administration (FDA) has approved KalVista Pharmaceuticals' Ekterly (sebetralstat) as the first and only ...
Managed Healthcare Executive1d
FDA Approves Ekterly, First Oral Treatment for 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 ...