This Pharma Roundup episode reviews four major regulatory and clinical developments shaping early 2026. It begins with the Food and Drug Administration approval of Nuzolvence (zoliflodacin), a first-in-class oral antibiotic for uncomplicated gonorrhea offering a needle-free alternative amid rising antimicrobial resistance. The episode then covers the approval of Yartemlea for hematopoietic stem cell transplant–associated thrombotic microangiopathy, signaling a shift toward disease-modifying therapy. It also examines the FDA’s new risk-based flexibility in Chemistry, Manufacturing, and Controls requirements for cell and gene therapies. The episode concludes with a discussion of the partial clinical hold on ifinatamab deruxtecan following safety concerns related to interstitial lung disease.