Sanofi’s Sarclisa (isatuximab) has been approved by the Medicines and Healthcare product Regulatory Agency (MHRA) as part of a combination treatment for newly diagnosed multiple myeloma (MM).
Days after the European Commission (EC) granted approval, the UK’s Medicines and Healthcare Regulatory Agency (MHRA) has ...
Sanofi’s Sarclisa (isatuximab) has been approved by the European Commission (EC) to treat adults with newly diagnosed ...
Paris: Following the adoption of a positive opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products ...
Approval based on positive pivotal ICARIA-MM phase 3 study using the China-based IsaFiRsT real-world study as bridging data, which demonstrated Sarclisa and the standard treatment Pd, improved ...
Sarclisa SC formulation added to Pd for the treatment of R/R MM met the co-primary endpoints in the IRAKLIA phase 3 study, demonstrating non-inferiority compared to Sarclisa IV IRAKLIA is the ...
The latest decision makes Sanofi's Sarclisa the first anti-CD38 therapy for transplant-ineligible patients with front-line ...
Sanofi SNY announced that the European Commission (“EC”) has granted marketing authorization to expand the use of its multiple myeloma (MM) drug, Sarclisa (isatuximab). With this nod ...
Sanofi (SNYNF, SNY) said the EU has approved Sarclisa in combination with a standard-of-care regimen, bortezomib, lenalidomide, and ...
Sanofi SNY announced that the phase III IRAKLIA study, which evaluated a fixed-dose subcutaneous (SC) formulation of its blood cancer drug, Sarclisa (isatuximab) for the treatment of relapsed or ...
Sanofi's Sarclisa SC formulation shows non-inferiority versus Sarclisa IV infusion in a late-stage study for treating ...