The EMA’s Committee for Medicinal Products for Human Use recommended Boehringer Ingelheim’s new lung drug Jascayd (nerandomilast) as part of a post-patent-cliff strategy as generic Ofev (nintedanib) approaches. Alongside that, the CHMP also recommended conditional approval for Novartis’s Vijoice (alpelisib) in PIK3CA-related overgrowth spectrum disorders. The EMA action signals additional momentum for Boehringer’s effort to maintain respiratory market presence as Ofev’s competitive pressure increases. It also highlights continued regulatory support for targeted therapies across rare and oncology-related indications. For biotech stakeholders, the decisions underline how label expansion in Europe can hinge on patent timelines and how fast-moving pipeline assets can benefit from coordinated CHMP guidance.