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FDA Calendar

The FDA Calendar provides a centralized view of upcoming PDUFA (Prescription Drug User Fee Act) decision dates for publicly traded biopharmaceutical companies. It helps investors and analysts track key FDA approval milestones that can significantly impact stock performance. Each entry includes the company name, ticker, drug candidate and expected decision date.
November 2025
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Nov 18, 2025
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Nov 30, 2025
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December 2025
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Dec 1, 2025
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Dec 5, 2025
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Dec 7, 2025
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Dec 12, 2025
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Dec 13, 2025
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Dec 15, 2025
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Dec 16, 2025
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Dec 20, 2025
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Dec 26, 2025
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Dec 30, 2025
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Dec 31, 2025
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Date
Ticker
Drug
Nov 18, 2025
Plozasiran
Nov 30, 2025
Transcon Cnp
Nov 30, 2025
Ziftomenib
Nov 30, 2025
Ziftomenib
Nov 30, 2025
Epcoritamab
Nov 30, 2025
EYLEA HD
Dec 01, 2025
Gepotidacin