EU CHMP
The European Medicines Agency is set to adopt opinions on whether marketing approval should be granted to five new products, including three orphans. A decision is also due on a previously-rejected Alzheimer’s drug that was under re-examination.
Asieris Pharmaceuticals' hexaminolevulinate, for treating high-grade squamous intraepithelial lesions, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Novartis’s ianalumab, for treating Sjögren’s disease, is also among the new drugs that the European Medicines Agency has started reviewing for potential pan-EU marketing approval.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
The European Medicines Agency’s human medicines committee, the CHMP, has voted against the pan-EU approval of Vanda Pharmaceuticals’ Iloperidone, marking a third rejection for the drug. The agency backed 12 products for EU approval and one for use outside of the bloc.
The European Medicines Agency said that Acoziborole Winthrop would simplify the treatment of first- and second-stage disease caused by Trypanosoma brucei gambiense.
Acoziborole, developed by Sanofi in collaboration with the Drugs for Neglected Diseases initiative, could potentially become the first single-dose oral treatment for sleeping sickness.
Iloperidone is among 13 new drugs that the European Medicines Agency is set to consider this week, as it decides whether they should be granted marketing approval.
Garetosmab, Regeneron Pharmaceuticals' treatment for adult patients with fibrodysplasia ossificans progressiva, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
The European Medicines Agency has recommended new uses for nine approved medicines, including Incyte's immunotherapy Zynyz which is poised to become the first EU treatment for squamous cell carcinoma of the anal canal.
The EMA has voted in favor of EU approval for five new products, including treatments for a rare, life‑threatening genetic disorder and for non‑cirrhotic MASH, and has also recommended reversing its earlier rejection of an orphan drug for chronic graft‑versus‑host disease.
The European Medicines Agency said that Sanofi’s Rezurock should be approved on a conditional basis for patients with chronic graft-versus host disease after reconsidering its initial decision not to recommend the drug.
The European Medicines Agency is set to adopt opinions on whether marketing approval should be granted to five new products, including therapies for a serious liver disease and an ultra‑rare genetic mitochondrial disorder.
In 2025, 43 drugs containing new active substances (NASs) were approved in the EU, and 2026 has already seen three NAS approvals with more expected soon. Also, for 1H 2026, the EU regulator has received 84 letters of intent for marketing applications for new drugs, of which 58 contain NASs.
Zidebactam/cefepime, Wockhardt's novel antibiotic treatment for resistant Gram-negative infections, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
The European Medicines Agency has said that Anavex’s Alzheimer’s candidate should not be authorized for use in the EU due to safety and efficacy concerns. Seven other products, including two new cancer drugs, received positive opinions.
The European Medicines Agency scheduled oral explanation meetings for Sanofi’s MS drug and two other products nearing the end of their EU regulatory review cycle. These meetings typically give companies a final chance to convince the agency their drugs merit approval.
Seven new products, including Anavex’s Alzheimer’s candidate and GSK’s add-on asthma therapy, are up for an opinion from the European Medicines Agency on whether they should be authorized for use in the EU.