FDA Extends Review Period for Ruxolitinib Cream for Vitiligo
The sNDA submission included data from the phase 3 TRuE-V clinical trial program.
The sNDA submission included data from the phase 3 TRuE-V clinical trial program.
The application is supported by data from the phase 3 TRuE-V clinical trial program.
This week we have news of changes to the storage of the Pfizer-BioNTech vaccine; A gene therapy gets Fast Track status by the FDA; Vitiligo cream shows promise in clinical trials; And outcomes in atherosclerotic cardiovascular disease are compared for different aspirin dosages.
Results from both studies demonstrated that ruxolitinib met the primary endpoint with a greater proportion of patients achieving F-VASI75 at week 24.