FDA approves Sanofi's Subcutaneous Sarclisa?

As of market creation, the FDA's expected decision date for the specified application is July 23, 2026. This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Sanofi's Subcutaneous Sarclisa in combination with approved standard-of-care regimens for the treatment of multiple myeloma across currently approved Sarclisa IV indications by August 6, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No." An approval is defined as: For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA) For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA) For biosimilars: FDA approval of a 351(k) application The following constitute qualifying approvals: Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restri