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Exclusive | How Replimune’s Drug Got Third Chance After White House Intervention - WSJ
Overview
Reporting says the White House intervened to give Replimune’s experimental drug a third chance in the regulatory process, showing direct political influence on a review. The intervention highlights how non-scientific pressures can reshape agency decisions and increases uncertainty for other developers. This case connects to recent patterns of FDA reversals that have already worried investors about approval predictability for novel therapies.
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ORGWhite HouseORGThe Wall Street JournalORGReplimuneLOCUnited States
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