A packed EMA committee room as CHMP members brief regulators on the November 2025 slate: ten new drug approvals and four indication expansions. A snapshot of Europe’s most influential decision-makers shaping the next wave of therapies. (Editorial Illustration)
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a packed set of recommendations during its November 10–13, 2025 meeting approving ten new medicines, granting four major indication extensions, and issuing decisions on multiple withdrawals and a key re-examination.
What You Need To Know
- CHMP recommended ten new medicines, including gene therapy, biosimilars, vaccines, and targeted oncology therapies.
- Four existing medicines including Koselugo and Minjuvi received indication extensions.
- Three marketing applications were withdrawn; one re-examination was upheld.
- Teplizumab and Wiskott-Aldrich gene therapy represent major advances in autoimmune and rare diseases.
Among the standout approvals is Dawnzera (donidalorsen), recommended for the prevention of recurrent hereditary angioedema attacks in adults and adolescents aged 12 and older. The committee also endorsed GalenVita, a radionuclide generator used to produce gallium chloride for PET imaging, expanding diagnostic capabilities for tumor evaluation.
The CHMP issued a positive opinion for Inluriyo (imlunestrant) for ESR1-mutated breast cancer, underscoring continued innovation in targeted hormone therapies. Equally notable was support for Teizeild (teplizumab), a first-in-class immunotherapy intended to delay stage 3 type 1 diabetes. Teplizumab benefited from EMA’s PRIME designation, reflecting its potential to shift the treatment paradigm in autoimmune diabetes.
Other approvals include Vacpertagen, an acellular pertussis vaccine, and Waskyra (etuvetidigene autotemcel), the first gene therapy for Wiskott-Aldrich syndrome one of the meeting’s most groundbreaking decisions.
Two biosimilars Ondibta (insulin glargine) and Osqay (denosumab) received positive opinions, alongside a generic product, Teduglutide Viatris, for short bowel syndrome. The committee also issued a hybrid approval recommendation for Enzalutamide Accordpharma for prostate cancer.
In addition to new medicines, CHMP endorsed therapeutic indication extensions for Koselugo, Minjuvi, Veyvondi, and Xerava, broadening patient access across oncology, hematology, and anti-infective care.
Three applications were withdrawn during or prior to the meeting: Insulin Aspart Injection, Nurzigma (pridopidine) for Huntington’s disease, and Ohtuvayre (ensifentrine) for COPD. CHMP also upheld its earlier decision not to consider Aqneursa (levacetylleucine) a New Active Substance following re-examination.
The broad set of recommendations highlights the diversity of innovation making its way into the European regulatory system from advanced gene therapies to precision oncology and vaccines. As these products proceed toward formal European Commission authorization, momentum across therapeutic categories is expected to carry into early 2026.