Praxis Precision Medicines says its experimental epilepsy drug relutrigine produced positive results in a key study, prompting an independent committee to recommend stopping the trial early for efficacy.
FDA solicits proposals for the CDER Center for Clinical Trial Innovation Bayesian Statistical Analysis demonstration project.
Praxis Precision Medicines says its experimental epilepsy drug relutrigine produced positive results in a key study, prompting an independent committee to recommend stopping the trial early for efficacy.
FDA solicits proposals for the CDER Center for Clinical Trial Innovation Bayesian Statistical Analysis demonstration project.
CBER says that a common deficiency that is driving a significant share of BLA-related complete response letters is manufacturing facility inspection readiness.
FDA lifts a partial clinical hold on one of Vanda Pharmaceuticals’ key tradipitant studies, clearing the company to expand dosing in an ongoing motion-sickness trial.
