Travere Therapeutics recently reported that the FDA has extended its review of the supplemental New Drug Application for FILSPARI (sparsentan) in focal segmental glomerulosclerosis (FSGS) to a new ...
The NDA submission is supported by efficacy data from the Phase 3 VIKTORIA-1 trial. Results demonstrated that in the wild-type patient cohort, the combination of gedatolisib and fulvestrant reduced ...