KalVista

FDA stop sign

Biotech

FDA's 'heavy workload' blamed for delaying KalVista's PDUFA date

KalVista has become the latest biotech to face delays to FDA decision-making, as the agency blames a “heavy workload” for pushing back a PDUFA date.

James Waldron Jun 16, 2025 4:33am

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KalVista sells Japanese rights for HAE drug to Kaken

Apr 8, 2025 8:35am

Photo of a person celebrating at the top of the mountain while the sun setsrises

KalVista's persistence with sebetralstat pays off in ph. 3 win

Feb 13, 2024 6:30am

Missed target failed trial trial failure

KalVista axes angioedema program over raised enzyme levels

Oct 4, 2022 10:32am

KalVista

KalVista bulks up executive team with CMO addition

May 3, 2021 8:00am

FDA Building 2

KalVista hit with a clinical hold on 2nd asset

Apr 20, 2021 8:05am