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FDA Issues Guidance On Expansion Cohorts In Clinical Trials Of Oncology Drugs

The FDA issued the final guidance document for first-in-human trial designs that consist of both dose escalation as well as multiple expansion.

United statesMarjoriee zettlerLe tourneauDrug administrationRegor pharmaceuticals incResearch to accelerate curesRegor pharmaceuticalsAccelerate curesChildren actStates foodExpansion cohortsFirst in human clinical trialsExpedite developmentOncology drugsStudy evaluatingSubjects with solid tumors

FDA Issues Guidance On Expansion Cohorts In Clinical Trials Of Oncology Drugs

The FDA issued the final guidance document for first-in-human trial designs that consist of both dose escalation as well as multiple expansion.

United statesMarjoriee zettlerLe tourneauDrug administrationRegor pharmaceuticals incResearch to accelerate curesRegor pharmaceuticalsAccelerate curesChildren actStates foodExpansion cohortsFirst in human clinical trialsExpedite developmentOncology drugsStudy evaluatingSubjects with solid tumors

Investegate |F Hoffmann-La Roche Ltd Announcements | F Hoffmann-La Roche Ltd: Roche receives positive CHMP opinion for Gavreto® (pralsetinib) for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer

Investegate |F Hoffmann-La Roche Ltd Announcements | F Hoffmann-La Roche Ltd: Roche receives positive CHMP opinion for Gavreto® (pralsetinib) for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer
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United statesNathalie meetzLevi garrawayPatrick barthKarsten kleineAmerican society of clinical oncologyVirtual scientific programmeEuropean unionPharmaceuticals industryCommittee for medicinal products human useAmerican cancer societyCstone pharmaceuticalsBlueprint medicines corporationDrug administrationWorld health organizationEuropean commission