Recent FDA decisions have substantially impacted drug markets and development trajectories. Novo Nordisk's Wegovy received accelerated approval for metabolic dysfunction-associated steatohepatitis (MASH), expanding its label and entering a competitive fatty liver disease market. In contrast, Pfizer announced failure of its sickle cell disease drug inclacumab in a Phase 3 trial for reducing vaso-occlusive crises, marking a setback following earlier acquisition-related challenges. Additionally, Vanda Pharmaceuticals secured a regulatory win as a federal appeals court ordered the FDA to reconsider a denied hearing related to Hetlioz for jet lag, indicating continuing legal-entwined regulatory dynamics.