US Pharma MarketingFDA to reconsider shock rejection of cell therapy Ebvallo. Could uniQure be next?
After a surprise rejection at the beginning of 2026, the FDA has agreed to reconsider a T-cell therapy based on the same single-arm trial that the agency had previously found problematic. After a surprise rejection in January, the FDA has agreed to reconsider a T-cell therapy based on the same single-arm trial that the agency had previously found problematic. The case could reignite investors’ hope of a potential reversal for uniQure's high-profile gene therapy, too. Biotech Cell & Gene Therapy Clinical Data Venture Capital Deals Research Medtech Devices Diagnostics AI and Machine Learning CRO Special Reports Trending Biologics Clinical…
After a surprise rejection in January, the FDA has agreed to reconsider a T-cell therapy based on the same single-arm trial that the agency had previously found problematic. The case could reignite investors’ hope of a potential reversal for uniQure's high-profile gene therapy, too.
Source: FierceBiotech