The EMA’s Committee for Medicinal Products for Human Use moved forward with potential replacement therapy for patients as generic versions of Boehringer Ingelheim’s Ofev (nintedanib) begin to hit markets. The CHMP recommended Boehringer’s Jascayd (nerandomilast) for approval, according to the report. At the same monthly meeting, CHMP also recommended conditional approval for Novartis’s Vijoice (alpelisib) for PIK3CA-related overgrowth spectrum disorders. The update extends to other positive recommendations, including antibody-drug conjugates and tablet formulation decisions in the same forum. The EMA action signals continued regulator support for active-mechanism changes in areas with looming patent cliffs, while also maintaining conditional pathways for targeted therapies in defined molecular or genetic disease categories.