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- FDA CBER director overrides review team to grant accelerated approval for Replimune's melanoma therapy TudriqevA senior official at the FDA's Center for Biologics Evaluation and Research stepped in to reverse a prior rejection by the agency's review panel. The director of the office of clinical evaluation a…
- UniQure files FDA priority review request for Huntington’s gene therapy AMT-130UniQure, a Dutch biotech, announced on Wednesday that it has submitted applications to the U.S. Food and Drug Administration seeking a priority review for its gene therapy AMT-130, which targets th…