Rilzabrutinib granted orphan drug designation in the US for two rare diseases with no approved medicines Designation granted for warm autoimmune hemolytic anemia and IgG4-related disease Rilzabrutinib is currently under regulatory review in the US, EU and China for potential use in immune thrombocytopenia Paris, April 3, 2025. The US Food and Drug Administration (FDA) has granted orphan drug d...
Qfitlia approved as the first therapy in the US to treat hemophilia A or B with or without inhibitors Qfitlia (fitusiran), the first antithrombin-lowering therapy in hemophilia, offers consistent protection with as few as six injections a year via a prefilled pen or vial and syringe Unique mechanism helps reduce the frequency of bleeding episodes for people with hemophilia Paris, March 28, 2025...
The U.S. Food and Drug Administration approved French drugmaker Sanofi's therapy, paving the way for a new type of treatment for patients 12 years of age and older with a rare disorder that prevents blood from clotting properly, the regulator said on Friday.
AbbVie and Sanofi occupy leading positions in the global immunology market. Each of them has advantages, as well as dark spots in the pipeline of drugs relative to the rival. In this article you will discover whether Sanofi or AbbVie is a more promising stock in the long term.
Dupixent approved as the first-ever biologic medicine in Japan for patients with COPD Following recent approvals in the EU, China, and the US, this approval was based on pivotal phase 3 results in adults with elevated eosinophils Approval marks the first new treatment approach for COPD in more than a decade in Japan and the sixth approved indication for chronic diseases with underlying type 2 i...
Chlamydia vaccine candidate granted fast track designation by the US FDA Chlamydia infection can contribute to pelvic inflammatory diseases in women, which can lead to pregnancy complications or infertility A phase 1/2 clinical study evaluating the immunogenicity and safety of the vaccine candidate is due to start in coming days Paris, March 26, 2025. The US Food and Drug Administration has gra...
Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis If approved, tolebrutinib would be the first and only brain-penetrant BTK inhibitor to both treat non-relapsing secondary progressive multiple sclerosis (MS) and slow disability accumulation independent of relapse activity Tolebrutinib has the potential to be the first therapy to targe...
Availability of the Q1 2025 Aide mémoire Paris, France – March 24, 2025. Sanofi announced today that its Q1 2025 Aide mémoire is available on the "Investors" page of the company's website: First quarter 2025 (sanofi.com) As for each quarter, Sanofi prepared this document to assist in the financial modelling of the Group's quarterly results.
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