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Story perspectives

FDA Rejects Skin Cancer Therapy Amid Leadership Turmoil

8/4/2025

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Story summary
  • Ed Silverman examines the FDA's rejection of Replimune's skin cancer therapy, highlighting internal conflicts.
  • Leadership turmoil at the FDA impacted the decision, despite some staff backing the therapy.
  • Medicare recipients will experience delays in cancer drug price relief due to new provisions in the One Big Beautiful Bill Act.
  • The act limits price negotiations, risking over $5 billion in potential Medicare savings.