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Amylyx has announced that it has started a process with the FDA and Health Canada to voluntarily discontinue the marketing authorizations for AMX0035 based on topline results from the Phase 3 PHOENIX trial
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Avoid ketorolac use during the third trimester of pregnancy (starting at 30 weeks of gestation) due to the risk of premature closure of the fetal ductus arteriosus and persistent pulmonary hypertension in the neonate (2,3,5,6)
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