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- FDA advisory panel backs experimental Replimune melanoma therapy after two prior rejectionsAn FDA advisory committee voted 10‑to‑3 to recommend the use of an experimental Replimune treatment for patients with advanced melanoma. The panel’s recommendation marks a shift after the agency p…
- UniQure prepares for FDA advisory committee on Huntington’s gene therapy amid rare-disease regulatory jittersUniQure said it is ready to present its Huntington's disease gene therapy, AMT-130, to an FDA advisory committee, as discussed in its Q2 earnings call. The company expects the FDA may schedule the…