KalVista Pharmaceuticals received prior regulatory approvals in the UK and the US, and the EMA adopted a positive opinion for its drug sebetralstat, with the EC expected to make a final decision.
3 reports, 1 independent
Updated Jul 25
Gone quiet
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New informationRepeats or wire copies
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What happened
KalVista Pharmaceuticals received prior regulatory approvals in the UK and the US, and the EMA adopted a positive opinion for its drug sebetralstat, with the EC expected to make a final decision.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.- FDA approved KalVista's novel treatment EKTERLY®.Sub-event
KalVista received prior regulatory approvals in the UK and US; EMA gave positive opinion for sebetralstat.1 source
EKTERLY was discovered in Salisbury, UK labs.1 source
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The entities involved
Coverage
Newest first; wire copies grouped- Business WireKalVista Pharmaceuticals Receives Positive CHMP Opinion for Sebetralstat for the Treatment of Hereditary Angioedema Attacks If approved, sebetralstat will be the first and only oral on-demand treatme
- Business WireKalVista Pharmaceuticals Announces UK MHRA Approval of EKTERLY® (sebetralstat), First and Only Oral On-demand Treatment for Hereditary Angioedema EKTERLY to be added to the Orphan Register and awarde
- Business WireKalVista Pharmaceuticals Provides Operational Update and Fiscal Year 2025 Financial Results – Received FDA approval of EKTERLY® (sebetralstat)—the first and only oral on-demand treatment for heredita