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FDA Rejects Experimental Melanoma Drug Twice Over Study Design
The Food and Drug Administration turned down an experimental melanoma treatment on two separate occasions after raising questions about how the supporting clinical study was structured. The agency cited concerns with the trial's design as the basis for both rejections.
May 29, 7:31 AM·1m read1 source
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The Food and Drug Administration rejected an experimental melanoma drug on two occasions because it questioned the design of the clinical study submitted by the developer. Agency reviewers determined that the trial structure did not meet standards required to support approval. The same concerns were cited in both rejection decisions.
No additional details on the drug's developer, specific trial endpoints, or next steps were provided in the report.
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