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- 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…
- FDA announces reorganization and CTAGTAC votes on Duchenne muscular dystrophy and melanoma therapiesThe FDA disclosed a major internal reorganization aimed at streamlining its operations and improving efficiency across its divisions. The agency’s Cellular, Tissue, and Gene Therapies Advisory Com…