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PDUFA
Fierce Biotech
FDA 'on track' to meet all PDUFA dates, Marty Makary says
All the figurative FDA trains are running on time, according to the agency’s leader Marty Makary, M.D.
Gabrielle Masson
Jun 18, 2025 4:00am
Fierce Biotech
FDA's 'heavy workload' blamed for delaying KalVista's PDUFA date
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FDA misses target date for GSK's Nucala in COPD
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FDA staff cuts threaten upcoming user fee renewal talks: Reuters
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FDA misses decision deadline for Novavax COVID vaccine
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