November 11, 2026

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The European Post

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November 11, 2026

Newsletter

The European Post

Policy • Diplomacy • strategic insight

LATEST
Drone Strategy Review Finds EU Single Market Stuck On PaperNew Canada EU Alliance Pairs Data Rules With Defence LinksSupermarket Cyberattacks Expose EU Gap On Old ControllersStand-Alone European Social Fund Wins €124 Billion Backing From MEPsGreenhouse Gas Emissions Fall 1.6 percent As Nine Capitals Drift Off TrackHumanitarian Action Reform Puts Starvation Warfare in EU SightsSerbia Accession Talks Get a Fresh Start After Vučić Loses PowerJapanese Carmakers Lobby Against Made in Europe Rules For EV SupportMexico City Awaits Senate Vote To Activate EU-Mexico Trade AgreementTokyo Hosts Japan-EU Financial Regulatory Forum On AI And Cyber RiskBangkok Bets On A Thai-EU FTA To Climb The Global Value ChainIndonesia EU CEPA Signing Races a January Tariff CliffCustoms Reform Makes Online Platforms Answer As Importers In EUGeographical Indications Dialogue Tests EU Farm Brand DefenceCivil Protection Mechanism Carries Ukraine’s Winter NeedsTobacco Taxation Directive Stalls As Malta Alone Withholds ConsentAkzoNobel Axalta Merger Clears Brussels With Refinish SalePhilippines Trade Deal Tests Brussels on Human Rights PledgesAkzoNobel Axalta Merger Cleared With Refinish SaleAir Passenger Rights Reform Keeps Three-Hour ThresholdDrone Strategy Review Finds EU Single Market Stuck On PaperNew Canada EU Alliance Pairs Data Rules With Defence LinksSupermarket Cyberattacks Expose EU Gap On Old ControllersStand-Alone European Social Fund Wins €124 Billion Backing From MEPsGreenhouse Gas Emissions Fall 1.6 percent As Nine Capitals Drift Off TrackHumanitarian Action Reform Puts Starvation Warfare in EU SightsSerbia Accession Talks Get a Fresh Start After Vučić Loses PowerJapanese Carmakers Lobby Against Made in Europe Rules For EV SupportMexico City Awaits Senate Vote To Activate EU-Mexico Trade AgreementTokyo Hosts Japan-EU Financial Regulatory Forum On AI And Cyber RiskBangkok Bets On A Thai-EU FTA To Climb The Global Value ChainIndonesia EU CEPA Signing Races a January Tariff CliffCustoms Reform Makes Online Platforms Answer As Importers In EUGeographical Indications Dialogue Tests EU Farm Brand DefenceCivil Protection Mechanism Carries Ukraine’s Winter NeedsTobacco Taxation Directive Stalls As Malta Alone Withholds ConsentAkzoNobel Axalta Merger Clears Brussels With Refinish SalePhilippines Trade Deal Tests Brussels on Human Rights PledgesAkzoNobel Axalta Merger Cleared With Refinish SaleAir Passenger Rights Reform Keeps Three-Hour Threshold

EMA New Medicines Include An Oral Obesity Pill Called Foundayo

Jóhannes Guðnason
Legislative Affairs Editor, Health and Wellbeing

Amsterdam: The European Medicines Agency recommended six new medicines for approval at its October meeting, and the EMA new medicines list includes an oral obesity treatment. The Committee for Medicinal Products for Human Use met from 12 to 15 October 2026, and the agency published its highlights on 16 October. All opinions now go to the European Commission for a final decision.

The headline product is Foundayo, containing orforglipron, from Eli Lilly Nederland. It is a once-daily tablet recommended for the treatment of obesity and type 2 diabetes in adults. A second oncology product, Rasonque with daraxonrasib from Revolution Medicines Netherlands, targets metastatic pancreatic adenocarcinoma in adults who have had at least one previous treatment, and the agency reviewed it in phases under its Cancer Medicines Pathfinder.

Rare disease patients also gain. Yuviwel, with navepegritide from Ascendis Pharma, treats achondroplasia in children and has orphan status. Kizfizo, a temozolomide product from Orphelia Pharma, is a hybrid application for glioblastoma multiforme in adults and malignant glioma in children, and it also carries orphan status.

Two biosimilars complete the EMA new medicines group. Fovlussea, a ranibizumab biosimilar from Accord Healthcare, covers wet age-related macular degeneration and several other eye conditions linked to diabetes and vein occlusion. Neuzafy, a filgrastim biosimilar from CuraTeQ Biologics, treats neutropenia in adults and children.

Beyond the EMA new medicines list, the committee backed five extensions of indication, for the AstraZeneca H5N1 pandemic influenza vaccine, Kyinsu, Talvey, Tryngolza and Tukysa. EMA’s highlights list only the product names for these, so the new wording of each indication is not confirmed here. The committee confirmed its refusal of Yartemlea, narsoplimab, for thrombotic microangiopathy linked to stem cell transplantation, after a re-examination.

There were smaller decisions too. Two extension applications were withdrawn, for Ibrance and Truqap, and the committee did not recommend extending Mylotarg to children newly diagnosed with acute myeloid leukaemia. It also recommended changing the legal status of the Nyxoid naloxone nasal spray so that it is available without prescription.

The agency’s running totals show the pace of the year. With the six positive opinions in October, the EMA new medicines tally for 2026 reaches 72 positive opinions on new medicines, against 8 negative ones, and 97 positive extension opinions. There were no negative opinions on new medicines this month.

The Commission usually takes about two months to turn a committee opinion into an authorisation. Patients and health ministries will watch how quickly the obesity pill and the pancreatic cancer treatment reach national reimbursement systems, because the EMA new medicines recommendation settles safety and efficacy but not price or access.

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