Lipoic acid offers no improvements in walking speed or other outcomes in patients with progressive multiple sclerosis ...
Sanofi provides update on tolebrutinib regulatory submission in non-relapsing secondary progressive multiple sclerosisParis, December 24, 2025.
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FDA issues CRL to SNY's regulatory filing for multiple sclerosis drug
Sanofi SNY announced that the FDA has issued a complete response letter (CRL) to its new drug application (NDA), seeking approval for its investigational Bruton's tyrosine kinase (BTK) inhibitor, ...
Sanofi (SNY) stock is in focus as the company agrees to acquire Dynavax Technologies (DVAX) and the FDA rejects its multiple ...
Sanofi’s multiple sclerosis hopeful tolebrutinib faced dual setbacks on Monday, with a late-stage failure in one form of the disease and yet another regulatory setback in another.
Sanofi will not be pursuing approval of tolebrutinib for PPMS, and an FDA decision on the therapy in nonrelapsing SPMS will ...
Investing.com -- Sanofi SA (EPA:SASY) announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application of tolebrutinib, which was ...
Findings showed the study met its primary endpoint demonstrating a reduction in disability accumulation with tolebrutinib compared with placebo. Tolebrutinib was found to delay disability progression ...
Tolebrutinib, which Sanofi acquired in a $3.7 billion buyout, failed a Phase 3 study in “primary progressive” multiple ...
Sanofi provides update on tolebrutinib regulatory submission in non-relapsing secondary progressive multiple sclerosis: Paris Friday, December 26, 2025, 13:00 Hrs [IST] The US Foo ...
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