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- FDA signals openness to innovative trial designs for psychedelic therapiesFDA regulators said they are willing to consider more flexible approaches for evaluating psychedelic medicines. The agency noted that studies could use active comparators instead of placebo, which…
- FDA pauses enrollment in Biohaven's epilepsy trials after earlier depression trial failureFDA placed a partial clinical hold on Biohaven's Kv7 potassium channel agonist, BHV-7000 (opakalim), halting enrollment of new patients in two late-stage focal epilepsy studies. The pause follows…