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FDA's New and Supplemental Approvals in December

The FDA concluded the year by approving at least nine new therapies in December, including a subcutaneous formulation of Opdivo, potentially extending its lifecycle amidst looming patent cliffs for IV versions of major PD-1 inhibitors.

The FDA wrapped up the year with the approval of at least nine new therapies in December. Among these approvals was a subcutaneous formulation of Opdivo, which could play a crucial role in extending the product's lifecycle. This development comes at a time when the IV versions of major PD-1 inhibitors are facing impending patent cliffs, highlighting the importance of innovation and adaptation in the pharmaceutical industry.
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Reference News

[1]
FDA's new and supplemental approvals in December - BioCentury
biocentury.com · Jan 10, 2025

FDA approved nine new therapies in December, including a subcutaneous Opdivo formulation, potentially extending its life...

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