FDA's NDA And BLA Approvals: Kymriah, Vabomere, Cyltezo
Original new drugs and biologics recently approved by US FDA.
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Risk Evaluation and Mitigation Strategy for Kymriah requires the acute lymphoblastic leukemia treatment be administered by certified centers, while a postmarketing study will assess safety over 15 years. FDA's early approval reflects efforts by the biologics center and new cross-cutting Oncology Center for Excellence to implement a more collaborative review model.