The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of ...

Paris: Sanofi has announced that the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) ...

Sarclisa recommended for EU approval by the CHMP to treat transplant-ineligible newly diagnosed multiple myelomaRecommendation based on IMROZ ...

EMA human medicine committee recommends approval of Sanofi’s Sarclisa to treat transplant-ineligible newly diagnosed multiple myeloma: Paris Saturday, November 16, 2024, 09:00 H ...

Recommendation based on IMROZ phase 3 study demonstrating Sarclisa in combination with ... of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem ...

If approved, this Sarclisa-based combination could establish a new standard-of-care treatment approach for patients in the EU, helping to address a critical care gap in multiple myeloma treatment ...

"The positive CHMP opinion is an important step forward for people with transplant-ineligible newly diagnosed multiple myeloma for whom effective front-line therapy may improve long-term outcomes. If ...

Sarclisa recommended for EU approval by the CHMP to treat transplant-ineligible newly diagnosed multiple myeloma Recommendation based on IMROZ phase 3 study demonstrating Sarclisa in combination ...

has adopted a positive opinion recommending the approval of Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed ...

The drugmaker has won an appeal against NICE's recent final draft guidance on Sarclisa (isatuximab) as a regimen alongside ...

The marketing applications with the EMA and FDA are for J&J and partner Genmab's Darzalex Faspro version of the anti-CD38 ...