The EMA’s Committee for Medicinal Products for Human Use recommended Boehringer Ingelheim’s nerandomilast, branded as Jascayd, as a replacement option as generic nintedanib (Ofev) approaches the patent cliff. The recommendation arrives as European regulators also weigh other advanced therapies, including Novartis’ Vijoice (alpelisib) conditional approval for PIK3CA-related overgrowth spectrum disorders. These decisions matter for companies trying to defend—or replace—commercial franchises in fibrotic disease, where timing of regulator action can determine share capture as branded exclusivity erodes. The EMA meeting also generated positive recommendations for additional antibody-drug conjugates from AstraZeneca and Astellas and for a tablet formulation of Novo Nordisk’s Wegovy (semaglutide).