Food and Drug Administration (FDA)

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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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FDA hopes AI can deliver 'rapid or instant' reviews

Jun 11, 2025 12:45pm
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FDA refuses Axsome filing for former Pfizer fibromyalgia asset

Jun 9, 2025 12:27pm
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At cell and gene roundtable, officials pledge to slash regulations

Jun 5, 2025 2:50pm
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Lack of global regulatory alignment spurs bad actors, FDA says

May 9, 2024 10:15am
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Pharma heads for cancer first line, causing early-stage rethink

Nov 17, 2023 3:00am