The FDA approved Roivant/Priovant’s oral JAK1/TYK2 inhibitor brepocitinib (Lisraya) for dermatomyositis, giving the company its first regulatory win in a rare autoimmune indication. The approval supports a once-daily oral approach for patients who previously relied on high-dose steroids and other immune-suppressing regimens. In a separate oncology regulatory move, the FDA granted fast track designation to CytomX’s EpCAM-directed masked antibody-drug conjugate varsetatug masetecan (Varseta-M; CX-2051) for relapsed/refractory metastatic colorectal cancer. The designation follows phase 1 dose-expansion results, including a confirmed objective response rate that rose to 32% at the highest studied dose. Together, the approvals underscore continued FDA willingness to accelerate access for targeted therapies in high-unmet-need patient groups, spanning autoimmune inflammation and hard-to-treat gastrointestinal cancers.