The White House pushed health officials to re-examine the Food and Drug Administration’s repeated rejections of an advanced melanoma medication from Replimune Group REPL 85.68%increase; green up pointing triangle, people familiar with the matter said.
The FDA had declined to approve Replimune’s treatment in July last year and then again in April, saying the data from the trial, in which all patients received the experimental drug with no comparison group, fell short of proving to the agency that it worked. The FDA also said the mix of patients enrolled made the results hard to interpret.
After its application was rejected for the second time, Replimune representatives met with the White House in early May, arguing the rejections didn’t match up with the Trump administration’s desire to help terminally ill patients.
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