The FDA approved Corcept Therapeutics’ Lifyorli (relacorilant) ahead of schedule for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. The agency cleared the oral, selective glucocorticoid receptor antagonist in combination with nab-paclitaxel for three cancer types in patients who have received up to three prior lines of therapy. Hours later, Denali Therapeutics won an accelerated approval for Avlayah (tividenofusp alfa) for mucopolysaccharidosis type II (Hunter syndrome). The decision came ahead of the company’s April 5 PDUFA date, underscoring the FDA’s continued willingness to use expedited pathways in rare disease. Both approvals arrive after a period of heightened scrutiny on evidence packages in rare disease therapy, including recent denials in the category. For Corcept and Denali, the updates reduce clinical and regulatory uncertainty and provide near-term momentum for commercial planning. Together, the actions highlight a two-track FDA playbook across oncology and rare genetic disease—fast routes when the evidence supports benefit, with label expansions when appropriate.