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FDA's December Calendar Features Nine PDUFA Dates

The FDA has outlined target action dates for nine applications in December, including treatments for rare diseases and a new subcutaneous formulation of Opdivo.

The U.S. Food and Drug Administration (FDA) has scheduled target action dates for at least nine Prescription Drug User Fee Act (PDUFA) applications this December. Among these, three are focused on treatments for rare diseases, highlighting the agency's commitment to addressing unmet medical needs. Additionally, one of the applications under review is for a subcutaneous formulation of Opdivo, a move that could offer patients a more convenient administration option compared to the current intravenous form. This month's PDUFA dates underscore the FDA's ongoing efforts to evaluate and potentially approve new therapies that could significantly impact patient care.
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Reference News

[1]
Nine PDUFA dates on FDA's December calendar
biocentury.com · Dec 4, 2024

FDA targets action dates for nine applications this month, including three for rare diseases and one for Opdivo's subcut...

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