DILI
Sanofi calls FDA rejection of potential MS blockbuster tolebrutinib “unexpected” amid evolving agency views on benefit–risk
Sanofi; tolebrutinib; multiple sclerosis; nrSPMS; BTK inhibitor; FDA rejection; complete response letter; DILI; primary progressive MS; Perseus trial; evolving FDA perspectives
Sanofi calls FDA rejection of potential MS blockbuster tolebrutinib “unexpected” amid evolving agency views on benefit–risk
Sanofi; tolebrutinib; multiple sclerosis; nrSPMS; BTK inhibitor; FDA rejection; complete response letter; DILI; primary progressive MS; Perseus trial; evolving FDA perspectives