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 ...

Paris: Following the adoption of a positive opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products ...

Sanofi’s Sarclisa (isatuximab) has been approved by the European Commission (EC) to treat adults with newly diagnosed ...

The latest decision makes Sanofi's Sarclisa the first anti-CD38 therapy for transplant-ineligible patients with front-line ...

The FDA had approved Sarclisa for a similar use in the United States in September 2024. SNY's Zacks Rank & Stocks to Consider Sanofi currently carries a Zacks Rank #3 (Hold).

Sanofi's Sarclisa has been an also-ran in the anti-CD38 antibody class behind Johnson & Johnson and Genmab's blockbuster Darzalex, but now has a chance to steal some of the spotlight. The FDA has ...

Sanofi (SNYNF, SNY) said the EU has approved Sarclisa in combination with a standard-of-care regimen, bortezomib, lenalidomide, and ...

Sanofi’s anti-CD38 antibody Sarclisa has struggled to make headway against Genmab and Johnson & Johnson’s rival Darzalex since it was first approved for multiple myeloma, but new data from the ...

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 ...