STAT+: Travere’s drug for a kidney disease doesn’t improve kidney function. The FDA approved it anyway
statnews.com·Apr 16, 2026
The FDA has recently approved the first treatment for focal segmental glomerulosclerosis (FSGS), a rare kidney disease, demonstrating its regulatory flexibility amid ongoing discussions about drug approvals for rare conditions.
The FDA's recent approval of the first treatment for focal segmental glomerulosclerosis (FSGS) demonstrates its willingness to exercise regulatory flexibility for rare diseases, signaling potential opportunities for healthtech and biotech companies focusing on orphan drugs. This could pave the way for similar approvals in the rare disease sector, making it a strategic area for investment and innovation.