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- FDA launches expedited IND pilot program, integrating public feedback into qualification criteriaThe FDA announced that its long-awaited expedited investigational new drug (IND) pilot program has started accepting applications as of Tuesday. Agency leaders Karim Mikhail and Michael Davis, new…
- Axoltis reports Phase 2 failure of experimental ALS drug but notes small signalAxoltis Pharma, a French biotech, announced that its Phase 2 trial of an experimental ALS therapy did not meet its primary endpoints. The company said the data were noisy but observed a modest tre…