A U.S. regulatory decision on tolebrutinib will again be delayed while a late-stage trial of the drug for a different form of ...

French drugmaker Sanofi on Monday flagged another delay to a U.S. regulatory decision for its experimental multiple sclerosis ...

Shares of Sanofi slumped on Monday as the French drugmaker said a U.S. regulatory review of its multiple-sclerosis drug won’t ...

Shares of French pharmaceutical group Sanofi fell 4% on Monday after it flagged another delay to a U.S. regulatory decision ...

Sanofi provides update on tolebrutinib in primary progressive multiple sclerosis PERSEUS phase 3 study in primary progressive multiple sclerosis did not meet its primary endpoint in delaying time to ...

Tolebrutinib received provisional approval in the United Arab Emirates in July 2025 for non-relapsing secondary progressive ...

Sanofi provides update on tolebrutinib regulatory submission in non-relapsing secondary progressive multiple sclerosis Ongoing discussions with the FDA regarding nrSPMS application have indicated ...

Sanofi’s multiple sclerosis hopeful tolebrutinib faced dual setbacks on Monday, with a late-stage failure in one form of the ...

Sanofi will not be pursuing approval of tolebrutinib for PPMS, and an FDA decision on the therapy in nonrelapsing SPMS will ...

Tolebrutinib was one of three oral BTK inhibitors that Sanofi acquired as part of its $3.7 billion buyout of Principia ...

So continues the rocky path for the drug, which Sanofi picked up in its $3.7 billion buyout of Principia Biopharma back in ...

Sanofi’s experimental multiple sclerosis drug got hit with two setbacks on Monday: a regulatory delay in the US as well as a failure in a late-stage clinical trial.