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Strategies to Facilitating Accelerated Drug Development
February 17, 2025The article details FDA's Accelerated Drug Development, including guidelines, definition of serious conditions, strategies, features, and withdrawal reasons. -
FDA Grants Accelerated Approval to Rozlytrek
August 19, 2019The U.S. Food and Drug Administration (FDA) granted accelerated approval to Rozlytrek (entrectinib), a treatment for adult and adolescent patients whose cancers have the specific genetic defect ... -
Cancer drug with accelerated approval fails Phase III trial
January 24, 2019Results did not confirm the clinical benefit of Lartruvo in combination with doxorubicin compared to doxorubicin alone… -
FDA under fire over accelerated approval data demands
August 17, 2017Ex-FDA commissioner Robert Califf defended the FDA's accelerated approvals.
Pharma Sources Insight January 2025
