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FDA approves Evive Biotech’s Ryzneuta for the management of chemotherapy-induced neutropenia (incidence of infection, as manifested by febrile neutropenia). Ryzneuta, is a 20 mg/mL solution in a singledose, prefilled syringe, injection. Ryzneuta is subcutaneously administered recombinant fusion protein, efbemalenograstim alfa-vuxw. Evive Biotech had submitted the Biologics License Application (BLA) with FDA in March 2021, and receives the FDA approval in November 2023.  Efbemalenograstim alfa was first approved in China in May 2023 and under regulatory review in Europe.

Approved Label

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