Mississippi (geographic location)

Sanofi calls FDA rejection of potential MS blockbuster tolebrutinib “unexpected” amid evolving agency views on benefit–risk

3 weeks ago talkbio0Tagged BTK inhibitor, Complete Response Letter, DILI, Mississippi (geographic location), Multiple Sclerosis, nrSPMS, PERSEUS trial, perspectives, Progressive, Rejection, sanofi, Tolebrutinib, United States Food and Drug Administration

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

3 weeks ago talkbio0Tagged BTK inhibitor, Complete Response Letter, DILI, Mississippi (geographic location), Multiple Sclerosis, nrSPMS, PERSEUS trial, perspectives, Progressive, Rejection, sanofi, Tolebrutinib, United States Food and Drug Administration

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

3 weeks ago talkbio0Tagged BTK inhibitor, Complete Response Letter, DILI, Mississippi (geographic location), Multiple Sclerosis, nrSPMS, PERSEUS trial, perspectives, Progressive, Rejection, sanofi, Tolebrutinib, United States Food and Drug Administration

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

3 weeks ago talkbio0Tagged BTK inhibitor, Complete Response Letter, DILI, Mississippi (geographic location), Multiple Sclerosis, nrSPMS, PERSEUS trial, perspectives, Progressive, Rejection, sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; multiple sclerosis; nrSPMS; BTK inhibitor; FDA rejection; complete response letter; DILI; primary progressive MS; Perseus trial; evolving FDA perspectives

The 5 Most Painful Clinical Trial Failures of 2025

1 month ago talkbio0Tagged 2025, approvals, Clinical Trial Failures, gene therapy, Mississippi (geographic location), Muscular Dystrophy, Duchenne, United States Food and Drug Administration

clinical trial failures; 2025; biotech; gene therapy; MS; DMD; FDA approvals

Sanofi’s multiple sclerosis drug tolebrutinib flunks Phase 3 in PPMS and faces another FDA PDUFA delay

1 month ago talkbio0Tagged BTK inhibitor, Clinical trial failure, Deferred, Mississippi (geographic location), Multiple Sclerosis, non-relapsing secondary progressive, nrSPMS, Parts per million (qualifier value), PDUFA, Progressive, Regulatory Setback, Review [Publication Type], sanofi, Tolebrutinib, United States Food and Drug Administration

Sanofi; tolebrutinib; multiple sclerosis; primary progressive multiple sclerosis; PPMS; non-relapsing secondary progressive MS; nrSPMS; Phase 3 PERSEUS trial; PDUFA delay; FDA review; BTK inhibitor; clinical trial failure; regulatory setback

European Commission Imposes €463 Million Fine on Teva for Anti-Competitive Practices in MS Drug Market

1 year ago talkbio0Tagged Commission, competition, Copaxone, Dominance, European (ethnic group), Market, Mississippi (geographic location), MS, tactics, Teva

Teva, European Commission, fine, MS drug, competition tactics, Copaxone, market dominance

Progentos Secures $65 Million for Groundbreaking Remyelination Therapy in Multiple Sclerosis Treatment

2 years ago talkbio0Tagged Biotechnology, Clinical Trials, Mississippi (geographic location), Multiple Sclerosis, nervous system repair, Neurodegenerative Disorders, Progentos, Remyelination

Progentos, funding, remyelination therapy, multiple sclerosis, MS treatment, clinical trials, neurodegenerative diseases, nervous system repair, biotechnology.