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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April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.