The FDA delivered back-to-back rare-disease and oncology wins Wednesday, highlighting a still-active accelerated-approval pathway for rare conditions. Corcept Therapeutics’ oral selective glucocorticoid receptor antagonist Lifyorli (relacorilant) was approved for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with nab-paclitaxel—cleared nearly four months ahead of schedule. The approval covers three cancer types after up to three prior lines of therapy. Separately, Denali Therapeutics’ Avlayah (tividenofusp alfa) received FDA accelerated approval for Hunter syndrome (mucopolysaccharidosis II), following recent scrutiny of other rare-disease gene therapies. Denali’s approval came ahead of its scheduled PDUFA date. For drug developers, these decisions underscore continued FDA receptivity to accelerated-approval submissions in rare diseases—while also reinforcing the agency’s willingness to advance oncology combo regimens on timely efficacy and benefit-risk signals.