At its November 2025 meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended ten new medicines for approval, marking a significant advancement in therapeutic options. Among the recommended products are donidalorsen from Otsuka Pharmaceutical, which targets specific therapeutic indications, and a recombinant pertussis vaccine from BioNet, showcasing the committee’s commitment to addressing both chronic and infectious diseases.
This meeting reflects the ongoing evolution of the pharmaceutical landscape, as regulatory bodies increasingly prioritize innovative therapies and biosimilars. The approval of new medicines not only enhances treatment options for patients but also impacts market dynamics, influencing sourcing strategies and portfolio management for pharmaceutical companies. As these recommendations move toward final approval, stakeholders in regulatory, QA/QC, and CMC sectors should prepare for potential shifts in their operational frameworks to accommodate these new entrants into the market.
Get started today with Solo access →
