Sanofi SA (SNY) on Wednesday said the U.S. Food and Drug Administration has extended by up to three months the timeline to review Sarclisa subcutaneous (SC) formulation in combination with standard-of-care to treat multiple myeloma across all currently approved U.S. indications of its intravenous (IV) formulation.
The new target action date is July 23, 2026.
If approved, Sarclisa would be the first anticancer treatment administered through an on-body injector (OBI), Sanofi said.
Additionally, On March 26, 2026, the European Medicines Agency committee had recommended the approval of Sarclisa as a subcutaneous treatment for multiple myeloma. A final decision is expected in the coming months.
Sarclisa is approved in nearly 60 countries for certain patients with newly diagnosed and relapsed or refractory multiple myeloma.
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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.