Sanofi SNY announced that the FDA has accepted its regulatory filing seeking approval for its investigational BTK inhibitor ...

The U.S. Food and Drug Administration is evaluating under priority review the regulatory submission of tolebrutinib to treat non-relapsing ...

The FDA review – which is due to be completed by 28th September – revolves around the results of the HERCULES trial which ...

FDA grants Priority Review status to Sanofi's tolebrutinib for the treatment of non-relapsing secondary progressive multiple ...

The US Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission by French pharma ...

Tolebrutinib is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory ...

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 ...

Sanofi is buying an immunology drug from Dren Bio, Inc. for up to $1.9 billion, in a deal it said will help it become a ...

Sanofi, one of the world’s largest pharmaceutical companies, has acquired the Serbian biopharmaceutical company Dren Bio for ...

Sanofi is set to acquire DR-0201 from Dren Bio for up to $1.9 billion, aiming to expand its autoimmune disease pipeline with ...

BRIDGEWATER, N.J., March 14, 2025 /PRNewswire/ -- Sanofi announced today the immediate adoption of influenza strains selected by the US Food and Drug Administration (FDA) to advance the ...