The FDA cleared Denali Therapeutics’ Hunter syndrome drug Avlayah (tividenofusp alfa) under an accelerated approval pathway, reversing recent scrutiny and rejection patterns for rare disease products. The agency’s decision comes amid political pressure on how it evaluates evidence in small populations. Separately, Corcept Therapeutics received an earlier-than-expected FDA nod for Lifyorli (relacorilant) with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, and primary peritoneal cancers. Corcept also secured an expedited timetable ahead of its PDUFA date, signaling continued openness to structured benefit-risk determinations when endpoints align. For rare disease and oncology alike, today’s approvals reinforce that regulators are still willing to accelerate pathways when clinical data support surrogate or measured clinical benefit, even as oversight continues to sharpen.