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- FDA’s new CBER and CDER heads back adaptive framework for rare disease therapiesNewly appointed permanent directors of FDA’s CBER and CDER, Karim Mikhail and Michael Davis, indicated they will continue the agency’s push for an adaptive regulatory framework aimed at rare diseas…
- Cue Biopharma's CUE-221 meets primary endpoint in phase 2 CSU trial, eyes phase 2b/3Cue Biopharma reported that its chronic spontaneous urticaria (CSU) candidate CUE-221 achieved the primary endpoint in a midstage study conducted in China. The trial enrolled 145 patients who rece…