EMA Committee Recommends Six New Medicines and Over-the-Counter Status for Nyxoid Nasal Spray
On 16 October 2026, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended six new medicines for approval across the European Union. The recommendations follow the committee's meeting held from 12 to 15 October 2026. Among the newly backed treatments is Foundayo, a daily oral tablet for weight management and type 2 diabetes in adults. The committee also backed Rasonque for adults with metastatic pancreatic cancer and Yuviwel for children with achondroplasia. Two biosimilar medicines, Fovlussea and Neuzafy, alongside a hybrid medicine called Kizfizo, also received positive opinions. In addition to recommending new treatments, the committee advised changing the legal status of Nyxoid, a nasal spray used for emergency treatment of known or suspected opioid overdoses, to make it available without a medical prescription. These positive opinions move the medicines forward to final decisions by the European Commission.
What was announced
The European Medicines Agency (EMA) published outcomes from its October 2026 human medicines committee meeting. Recommendations were issued to grant marketing authorizations for six new treatments. Foundayo is an oral tablet for adult weight management and type 2 diabetes. Rasonque is an oral treatment for adults with metastatic pancreatic cancer who have had previous treatment. Yuviwel treats achondroplasia, an inherited genetic condition affecting bone growth in children.
Two biosimilar medicines received positive opinions: Fovlussea for visual impairments such as wet age-related macular degeneration, and Neuzafy for neutropenia, a low white blood cell condition. The committee also backed Kizfizo, a hybrid medicine for brain tumors in adults and children. Additionally, five existing medicines received recommendations to extend their approved uses, including Kyinsu, Talvey, Tryngolza, Tukysa, and a pandemic influenza vaccine. Finally, the panel recommended changing Nyxoid, an emergency opioid overdose nasal spray, to a non-prescription status.
What it means
Patients in the European Union may soon gain access to these treatments after final decisions by the European Commission. Foundayo provides a daily pill alternative for weight management and diabetes, expanding options beyond injectable drugs. Changing Nyxoid to non-prescription status allows faster access to emergency care for suspected opioid overdoses.
Upon re-examination, the panel confirmed its refusal of Yartemlea for a serious stem cell transplant complication. Meanwhile, drug manufacturers withdrew applications to expand the use of breast cancer treatments Ibrance and Truqap. For Mylotarg, the panel declined an expanded indication for pediatric leukemia but agreed to update product documentation with trial data to guide healthcare professionals.
What the announcement does not tell us
Specific dates for when the European Commission will issue final decisions on these recommendations are not included in the report. The document does not state retail prices or national reimbursement details for individual European Union countries. Reasons why the manufacturers of Ibrance and Truqap withdrew their applications are also not provided. Furthermore, complete clinical trial data for the newly backed medicines is omitted from this summary.
How this was written
This analysis was written with AI from the official announcement below, using only facts that announcement states. The quoted wording is European Medicines Agency News’s own. Always check the original before acting on anything here.
Six new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended six medicines for approval at its October 2026 meeting.Rasonque (daraxonrasib)…, CHMP statistics Key figures from the October 2026 CHMP meeting are represented in the graphic below. © European Medicines Agency , CHMP statistics:…, Positive recommendations on new medicines, Foundayo International non-proprietary name (INN) orforglipron Marketing authorisation applicant Eli Lilly Nederland B.V. Therapeutic indication Treatment of…, Rasonque INN daraxonrasib Marketing authorisation applicant Revolution Me
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