FDA Reversal on uniQure Gene Therapy Is Another Sign of Renewed Regulatory Flexibility

MedCity News·Jun 17

✦ NabkaNews BriefAuto-summarized from multiple outlets · verify with the source

The FDA has reversed its stance on uniQure's gene therapy for Huntington's disease, allowing the company to seek approval. This decision is seen as part of a shift in regulatory approach at the FDA, with potential implications for other rare disease treatments. UniQure is now planning to submit its gene therapy for approval, with a submission expected as early as the third quarter.

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