{"citation":"Zavis, Global Medicines Approvals Monitor, decisions dated September 2026, compared with August 2026; registries read on 19 October 2026. https://www.zavis.ai/intelligence/global-medicines-approvals-monitor-october-2026","id":"global-approvals","title":"Global Medicines Approvals Monitor","asOf":"2026-10-19","period":"decisions dated September 2026, compared with August 2026; registries read on 19 October 2026","source":"openFDA (US Food and Drug Administration), the European Medicines Agency's medicines data, and ClinicalTrials.gov (US National Library of Medicine)","method":"US: original approvals in openFDA's Drugs@FDA data dated in the month. New molecular entities are NDAs of chemical type 1; new biologics are original BLAs of type 1. EU: centrally authorised human medicines in EMA's medicines data. A first-time authorisation is the first central authorisation of that active substance, excluding generics and biosimilars; opinions are those adopted by the CHMP in the month. Gulf link: studies on ClinicalTrials.gov that list the substance as an intervention, matched by its non-proprietary name, with at least one site in a GCC country.","caveats":["openFDA's Drugs@FDA data is updated weekly and can lag the FDA's announcements; it covers medicines reviewed by the FDA's drug centre, not vaccines, blood products or cell and gene therapies.","EU figures cover the centralised procedure only. A substance counts as new when no earlier central authorisation lists it.","Studies registered only under a code name, or only in other registries, are missed. Vaccines, cell therapies and blood products are not matched.","The condition most named in a medicine's registered studies is not its approved indication.","The CHMP does not meet in August, so August has no committee opinions."],"tables":[{"key":"volumes","caption":"New medicines cleared in the US and EU, by route","columns":["Route","September 2026","August 2026"],"rows":[["US new molecular entities and new biologics",9,7],["US other original biologic licences, incl. biosimilars",2,0],["EU first-time substance authorisations",3,2],["EU positive CHMP opinions",11,0],["EU negative CHMP opinions",1,0]]},{"key":"us_new","caption":"New molecular entities and new biologics approved in the US, September 2026","columns":["Medicine","Sponsor","Review","Condition most named in its registered studies","Registered studies","Studies with a GCC site"],"rows":[["Zanvastro (zilganersen)","Ionis Pharms","Priority","Alexander Disease",2,0],["Etcamah (camizestrant)","AstraZeneca","Standard","ER-Positive HER2-Negative Breast Cancer",17,2],["Isembyld (apitegromab)","Scholar Rock","Priority","SMA",7,0],["Pixclara (floretyrosine)","Telix","Priority","Glioma (Any Grade) in the Brain",2,0],["Lyrfigtu (lirafugratinib)","Elevar","Priority","FGFR2 Gene Fusion/Rearrangement",1,0],["Onswik (insulin efsitora alfa)","Eli Lilly","Standard","Type 2 Diabetes",5,0],["Juvmo (tavapadon)","AbbVie","Standard","Parkinson Disease",11,0],["Atebrioz (zilurgisertib)","Mirum","Priority","Fibrodysplasia Ossificans Progressiva (FOP)",1,0],["Emcitate (tiratricol)","Rare Thyroid","Priority","Allan-Herndon-Dudley Syndrome",5,0]]},{"key":"eu_new","caption":"Substances authorised in the EU for the first time, September 2026","columns":["Medicine","Holder","Therapeutic area","Designations","Registered studies","Studies with a GCC site"],"rows":[["Nezglyal (leriglitazone)","Minoryx Therapeutics","Adrenoleukodystrophy","Orphan, Exceptional circumstances",2,0],["Icotyde (icotrokinra)","Janssen-Cilag International","Psoriasis","None",4,0],["Zokovea (ensitrelvir)","Shionogi","COVID-19 virus infection","None",8,0]]},{"key":"eu_opinions","caption":"Opinions adopted by EMA's human medicines committee (CHMP), September 2026","columns":["Medicine","Active substance","Opinion","Type","Designations"],"rows":[["Frehemgo","denecimig","Positive","Substance new to EU central authorisation","None"],["Lifyorli","relacorilant","Positive","Substance new to EU central authorisation","Orphan"],["Povofortay","povorcitinib","Positive","Substance new to EU central authorisation","None"],["Sepalna","senaparib","Positive","Substance new to EU central authorisation","None"],["Zeydovio","glepaglutide","Positive","Substance new to EU central authorisation","None"],["Gevalka","ensartinib","Positive","Substance new to EU central authorisation","None"],["Klygefa","gefurulimab","Positive","Substance new to EU central authorisation","None"],["VaxRabeo","rabies vaccine (inactivated) for human","Positive","Substance new to EU central authorisation","None"],["Adcomfo","omalizumab","Positive","Biosimilar","None"],["Inijaq","tofacitinib","Positive","Generic","None"],["Ruxolitinib Zentiva","ruxolitinib","Positive","Generic","None"],["Xervyteg","Allogeneic faecal microbiota, pooled","Negative","Substance new to EU central authorisation","None"]]},{"key":"gulf_by_country","caption":"Registered studies of September 2026's new substances with a site in each GCC country","columns":["Country","Studies","Substances tested there"],"rows":[["United Arab Emirates",2,"camizestrant"],["Saudi Arabia",1,"camizestrant"],["Qatar",0,"None"],["Kuwait",0,"None"],["Bahrain",0,"None"],["Oman",0,"None"]]},{"key":"gulf_studies","caption":"Registered studies with a GCC site, for September 2026's new substances","columns":["Substance","Registry ID","GCC countries","Phase","Status"],"rows":[["camizestrant","NCT07647328","United Arab Emirates","Phase 3","Recruiting"],["camizestrant","NCT05952557","United Arab Emirates, Saudi Arabia","Phase 3","Active not recruiting"]]}]}