CDSCO Panel Approves Sanofi's Protocol Amendment to study Tolebrutinib Dr. Divya Colin20 April 2025 5:15 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved Sanofi's proposal...
Sanofi Tolebrutinib under USFDA priority review for multiple sclerosis Ruchika Sharma25 March 2025 12:15 PM ISTTolebrutinib is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.
Sanofi gets USFDA Breakthrough Therapy designation for multiple sclerosis therapy Tolebrutinib Ruchika Sharma17 Dec 2024 11:32 AM ISTParis: Sanofi has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Tolebrutinib for the...
USFDA grants Breakthrough Therapy designation to Sanofi tolebrutinib for non-relapsing secondary progressive multiple sclerosis Ruchika Sharma13 Dec 2024 3:53 PM ISTParis: Sanofi has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tolebrutinib...
Submit Modified Informed Consent Form with details: CDSCO Panel Tells Sanofi om Multiple Sclerosis Drug Tolebrutinib Dr. Divya Colin21 Jan 2024 6:00 PM ISTNew Delhi: Reviewing the Phase III clinical study protocol of Tolebrutinib presented by the drug major Sanofi, the Subject Expert Committee (SEC)...
USFDA places clinical hold on Phase 3 Tolebrutinib studies: Sanofi Ruchika Sharma2 July 2022 12:45 PM ISTThe FDA action was based on a limited number of cases of drug-induced liver injury that have been identified with tolebrutinib exposure in Phase 3...
Sanofi concludes acquisition of Principia Biopharma Ruchika Sharma29 Sept 2020 11:00 AM ISTParis: Drugmaker, Sanofi, recently announced that the company has successfully concluded the acquisition of Principia Biopharma Inc. for $100 per...
