PDUFA

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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

red tape delay stop error tie down stall

FDA misses PDUFA date for Stealth’s ultra-rare disease candidate

Apr 30, 2025 9:00am

FDA stop sign

FDA delays decision on Stealth's ultrarare disease med

Jan 23, 2025 9:45am

Delayed on hold

FDA delays decision on Moderna's RSV shot until the end of May

May 10, 2024 10:30am

delay FDA delay

Applied Tx’s pediatric rare disease prosect hits another snag

Mar 29, 2024 10:21am

journey path light sunshine stairs climb reach

Karuna's schizophrenia drug set for FDA decision in Q3 2024

Nov 29, 2023 10:00am