FDA Flags Liver Injury Risk In Sanofi's Rejected Multiple Sclerosis Drug - Sanofi (NASDAQ:SNY)

FDA Flags Liver Injury Risk In Sanofi's Rejected Multiple Sclerosis Drug - Sanofi (NASDAQ:SNY)

The FDA rejected Sanofi's MS drug tolebrutinib, citing liver injury risks, unclear benefits, and trial data that failed to show a favorable benefit-risk balance for any patient group.

FDA raises new questions with Sanofi's potential blockbuster MS drug in rejection letter

The FDA offered new details on why it rejected Sanofi's potential new multiple sclerosis drug late last year — a peek behind the veil that goes beyond what Sanofi said in public statements at the time ...

Tolebrutinib Receives FDA CRL for Nonrelapsing Secondary Progressive Multiple Sclerosis

The complete response letter (CRL) was issued following regulatory updates provided to Sanofi from the FDA.