FDA approved a single-dose, prefilled autoinjector presentation of Udenyca (pegfilgrastim-cbqv), a biosimilar pegfilgrastim administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia. The Udenyca autoinjector has a streamlined, easy-to-use design for use in both in-office and at-home settings of care.
FDA Center for Drug Evaluation and Research is soliciting grant applications from independent organizations to support meetings that bring together a broad range of stakeholders to explore, research, and address issues related to medical products, policy, and surveillance methods and systems.
