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Food and Drug Administration (FDA)
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
FDA hopes AI can deliver 'rapid or instant' reviews
Jun 11, 2025 12:45pm
FDA refuses Axsome filing for former Pfizer fibromyalgia asset
Jun 9, 2025 12:27pm
At cell and gene roundtable, officials pledge to slash regulations
Jun 5, 2025 2:50pm
FDA launces generative AI tool Elsa a month ahead of schedule
Jun 3, 2025 10:40am
Trial diversity nonprofit launches with FDA, Big Pharma vets
May 21, 2025 1:38pm
