Teva Pharmaceutical Industries Ltd. (TEVA) said Tuesday that the U.S. Food and Drug Administration has accepted for filing the company's Biologics License Application for XM02, a granulocyte colony-stimulating factor for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer.
Teva's BLA for XM02 was submitted to the FDA on Nov. 30. The proposed trade name for XM02 is NEUTROVAL.
XM02 was principally developed as a similar biological medicinal product to Neupogen, the trademark for filgrastim. In September 2008, XM02 received marketing authorization in the European Union where a biosimilars pathway exists.
XM02 was launched in several EU markets under the trade name TevaGrastim and will be launched in additional EU markets over time.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.