PDUFA

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Biotech

FDA rejects Capricor’s DMD cell therapy, asks for more data

The rejection raises questions about whether the new-look FDA leadership may be rowing back from some of the flexibility shown by the old regime.
Nick Paul Taylor Jul 11, 2025 9:18am
Clock in front of the subway

FDA 'on track' to meet all PDUFA dates, Marty Makary says

Jun 18, 2025 4:00am
FDA stop sign

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

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