US-approved medicines not yet registered in the Gulf
A tracker of 50 recent FDA approvals in cancer, rare disease, and gene and cell therapy, checked against the public drug lists we could search in Saudi Arabia and Abu Dhabi.
Last checked:
Of 50 medicines approved by the US FDA between February 2024 and September 2026, 35 did not appear in either the Saudi SFDA drugs list or the Abu Dhabi DoH drug code list when we checked on 17 October 2026.
"Not found" means the medicine did not appear in that public list on the date checked. It does not mean the medicine can never reach a patient in that country. Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner.
The tracker
Select a column heading to sort. Use the search box or the filter to narrow the list. On a phone, swipe the table sideways to see every column. The UAE column uses the Abu Dhabi DoH drug code list only, not the federal register.
Showing 50 of 50 medicines
| Emcitatetiratricol | Rare Thyroid Therapeutics | 28 Sep 2026 | MCT8 deficiency (Allan-Herndon-Dudley syndrome) | Not found | Not found | Not checked | Not checked |
| Atebriozzilurgisertib | Mirum Pharmaceuticals | 25 Sep 2026 | Fibrodysplasia ossificans progressiva | Not found | Not found | Not checked | Not checked |
| Lyrfigtulirafugratinib | Elevar Therapeutics | 23 Sep 2026 | FGFR2-rearranged cholangiocarcinoma | Not found | Not found | Not checked | Not checked |
| Fayuvirebisufligene etisparvovec | Ultragenyx | 17 Sep 2026 | Sanfilippo syndrome type A (MPS IIIA) in children (gene therapy) | Not found | Not found | Not checked | Not checked |
| Isembyldapitegromab | Scholar Rock | 11 Sep 2026 | SMA, age 2 and older, added to SMN2-targeted treatment | Not found | Not found | Not checked | Not checked |
| Zanvastrozilganersen | Ionis | 3 Sep 2026 | Alexander disease | Not found | Not found | Not checked | Not checked |
| Rasonquedaraxonrasib | Revolution Medicines | 26 Aug 2026 | Metastatic pancreatic cancer | Not found | Listed | Not checked | Not checked |
| Genglycospariglasgene brecaparvovec | Ultragenyx | 19 Aug 2026 | Glycogen storage disease type Ia (gene therapy) | Not found | Not found | Not checked | Not checked |
| Zenbexusiberdomide | Bristol Myers Squibb | 13 Aug 2026 | Multiple myeloma after at least one prior line, with daratumumab and dexamethasone | Listed | Not found | Not checked | Not checked |
| Tudriqevvusolimogene oderparepvec | Replimune | 6 Aug 2026 | Advanced melanoma after PD-1 therapy, with nivolumab (oncolytic virus) | Not found | Not found | Not checked | Not checked |
| Decnupazpivekimab sunirine | AbbVie | 27 May 2026 | Blastic plasmacytoid dendritic cell neoplasm | Not found | Not found | Not checked | Not checked |
| Beqalzisonrotoclax | BeOne Medicines | 13 May 2026 | Relapsed or refractory mantle cell lymphoma | Not found | Not found | Not checked | Not checked |
| Otarmenilunsotogene parvec | Regeneron | 23 Apr 2026 | OTOF-related severe hearing loss (gene therapy) | Not found | Not found | Not checked | Not checked |
| Kresladimarnetegragene autotemcel | Rocket Pharmaceuticals | 26 Mar 2026 | Severe leukocyte adhesion deficiency-I (gene therapy) | Not found | Not found | Not checked | Not checked |
| Avlayahtividenofusp alfa | Denali Therapeutics | 24 Mar 2026 | Hunter syndrome (MPS II) | Not found | Not found | Not checked | Not checked |
| Loargyspegzilarginase | Immedica | 23 Feb 2026 | Arginase 1 deficiency | Not found | Listed | Not checked | Not checked |
| Zycubocopper histidinate | Sentynl Therapeutics | 12 Jan 2026 | Menkes disease | Not found | Not found | Not checked | Not checked |
| Yartemleanarsoplimab | Omeros | 23 Dec 2025 | Transplant-associated thrombotic microangiopathy | Not found | Not found | Not checked | Not checked |
| Waskyraetuvetidigene autotemcel | Fondazione Telethon | 9 Dec 2025 | Wiskott-Aldrich syndrome (gene therapy) | Not found | Not found | Not checked | Not checked |
| Itvismaonasemnogene abeparvovec-brve | Novartis Gene Therapies | 24 Nov 2025 | SMA, age 2 and older (intrathecal gene therapy) | Not found | Listed | Not checked | Not checked |
| Komziftiziftomenib | Kura Oncology | 13 Nov 2025 | Relapsed or refractory NPM1-mutant AML | Not found | Not found | Not checked | Not checked |
| Kygevvidoxecitine and doxribtimine | UCB | 3 Nov 2025 | Thymidine kinase 2 deficiency | Not found | Not found | Not checked | Not checked |
| Forzinityelamipretide | Stealth BioTherapeutics | 19 Sep 2025 | Barth syndrome | Not found | Not found | Not checked | Not checked |
| Papzimeoszopapogene imadenovec | Precigen | 14 Aug 2025 | Recurrent respiratory papillomatosis (gene therapy) | Not found | Not found | Not checked | Not checked |
| Modeysodordaviprone | Chimerix (Jazz) | 6 Aug 2025 | H3 K27M-mutant diffuse midline glioma | Not found | Listed | Not checked | Not checked |
| Lynozyficlinvoseltamab | Regeneron | 2 Jul 2025 | Relapsed or refractory multiple myeloma after 4 or more prior lines | Not found | Not found | Not checked | Not checked |
| Zegfrovysunvozertinib | Dizal | 2 Jul 2025 | NSCLC with EGFR exon 20 insertion | Not found | Not found | Not checked | Not checked |
| Avmapki Fakzynja Co-Packavutometinib and defactinib | Verastem | 8 May 2025 | KRAS-mutated recurrent low-grade serous ovarian cancer | Not found | Not found | Not checked | Not checked |
| Zevaskynprademagene zamikeracel | Abeona Therapeutics | 28 Apr 2025 | Wounds in recessive dystrophic epidermolysis bullosa (gene-corrected cell sheets) | Not found | Not found | Not checked | Not checked |
| Qfitliafitusiran | Genzyme (Sanofi) | 28 Mar 2025 | Hemophilia A or B prophylaxis | Listed | Listed | Not checked | Not checked |
| Romvimzavimseltinib | Deciphera | 14 Feb 2025 | Tenosynovial giant cell tumor | Not found | Not found | Not checked | Not checked |
| Gomeklimirdametinib | SpringWorks Therapeutics | 11 Feb 2025 | NF1 plexiform neurofibromas | Not found | Listed | Not checked | Not checked |
| Datrowaydatopotamab deruxtecan | Daiichi Sankyo | 17 Jan 2025 | HR-positive, HER2-negative breast cancer | Not found | Listed | Not checked | Not checked |
| Tryngolzaolezarsen | Ionis | 19 Dec 2024 | Familial chylomicronemia syndrome | Not found | Listed | Not checked | Not checked |
| Ryoncilremestemcel-L | Mesoblast | 18 Dec 2024 | Steroid-refractory acute GvHD in children (cell therapy) | Not found | Not found | Not checked | Not checked |
| Bizengrizenocutuzumab | Merus | 4 Dec 2024 | NRG1 fusion-positive lung and pancreatic cancer | Not found | Not found | Not checked | Not checked |
| Ziiherazanidatamab | Jazz Pharmaceuticals | 20 Nov 2024 | HER2-positive biliary tract cancer | Not found | Not found | Not checked | Not checked |
| Revuforjrevumenib | Syndax | 15 Nov 2024 | Relapsed or refractory acute leukemia with KMT2A translocation | Not found | Listed | Not checked | Not checked |
| Kebilidieladocagene exuparvovec | PTC Therapeutics | 13 Nov 2024 | AADC deficiency (gene therapy) | Not found | Not found | Not checked | Not checked |
| Aucatzylobecabtagene autoleucel | Autolus | 8 Nov 2024 | Relapsed or refractory adult B-cell ALL (CAR-T) | Not found | Not found | Not checked | Not checked |
| Aqneursalevacetylleucine | IntraBio | 24 Sep 2024 | Niemann-Pick disease type C | Not found | Listed | Not checked | Not checked |
| Miplyffaarimoclomol | Zevra Therapeutics | 20 Sep 2024 | Niemann-Pick disease type C | Not found | Not found | Not checked | Not checked |
| Voranigovorasidenib | Servier | 6 Aug 2024 | Grade 2 IDH-mutant astrocytoma or oligodendroglioma | Listed | Listed | Not checked | Not checked |
| Tecelraafamitresgene autoleucel | Adaptimmune | 1 Aug 2024 | Synovial sarcoma, MAGE-A4 positive (engineered T-cell therapy) | Not found | Not found | Not checked | Not checked |
| Imdelltratarlatamab | Amgen | 16 May 2024 | Extensive-stage small cell lung cancer | Listed | Listed | Not checked | Not checked |
| Beqvezfidanacogene elaparvovec | Pfizer | 25 Apr 2024 | Moderate to severe hemophilia B (gene therapy) | Not found | Not found | Not checked | Not checked |
| Ojemdatovorafenib | Day One Biopharmaceuticals | 23 Apr 2024 | Relapsed or refractory pediatric low-grade glioma | Not found | Listed | Not checked | Not checked |
| Duvyzatgivinostat | Italfarmaco | 21 Mar 2024 | Duchenne muscular dystrophy, age 6 and older | Not found | Listed | Not checked | Not checked |
| Lenmeldyatidarsagene autotemcel | Orchard Therapeutics | 18 Mar 2024 | Metachromatic leukodystrophy, early-onset forms (gene therapy) | Not found | Not found | Not checked | Not checked |
| Amtagvilifileucel | Iovance Biotherapeutics | 16 Feb 2024 | Unresectable or metastatic melanoma after PD-1 therapy (cell therapy) | Not found | Not found | Not checked | Not checked |
How we built this list
US approvals. We took novel approvals from the FDA's own published lists: the CDER novel drug approval pages for 2024, 2025 and 2026, the CBER biologics license approval pages for the same years, and the CBER list of approved cellular and gene therapy products. Fayuvi was confirmed from the FDA press release of 17 September 2026. We kept medicines for rare diseases, for cancer, or gene and cell therapies. Brand name, generic name, developer, approval date and approved use come from those FDA pages and from the FDA Drugs@FDA database.
Saudi Arabia. We downloaded every entry of the SFDA drugs list, 9,173 entries on 17 October 2026, and searched each medicine by brand name, generic name and any known brand name used outside the US. We also checked the SFDA scientific news page for registration announcements. As a control, we confirmed that older therapies such as Zolgensma and Casgevy do appear in the same list.
United Arab Emirates. We searched the Abu Dhabi Department of Health drug code list (Drugs.xlsx, release dated 26 September 2026, on the DoH Shafafiya portal). This list covers medicines coded for use in Abu Dhabi. It is not the federal register, so we call it the Abu Dhabi DoH list. A listing there may reflect registration or another import route. The federal Emirates Drug Establishment online directory showed only eight sample entries when we checked, so federal and Dubai status is not confirmed for any medicine here.
Kuwait and Qatar. We did not find a public, searchable drug register for either country, so these columns say "Not checked".
Re-check. On 17 October 2026 we downloaded the Abu Dhabi DoH list again and re-ran all 50 medicines: every result matched. We also re-checked a sample of FDA approval dates against the live FDA 2026 page.
What "Not found" means
"Not found" means the medicine did not appear in that public list on 17 October 2026. It does not mean the medicine is unavailable in that country. Lists can lag behind approvals, a medicine can be listed under a different name, and some medicines reach patients through special import permits that never appear on a public list. "Listed" means we found at least one entry; it does not tell you whether a given hospital stocks it.
How patients reach these medicines before local registration
When a medicine is approved in the US but not yet registered locally, there are a few general routes. Each depends on the country, the medicine and the patient's medical situation, and none is guaranteed.
- Named patient or special import permission. In many countries a hospital or treating physician can ask the national regulator for permission to import an unregistered medicine for one named patient. The physician makes the medical case and the regulator decides. In Saudi Arabia, the SFDA runs a Named Patient Program and a Special Access Program. See our answers page for the sources.
- Manufacturer access programs. Some developers run expanded access programs for patients who cannot join a clinical trial. The developer sets eligibility, and the treating physician applies.
- Clinical trials. Some of these medicines are still being studied, and trials may be open in the region or abroad.
- Treatment at a specialist center. Many gene and cell therapies are only given at qualified treatment centers, so patients usually travel to receive them.
How Reserve Meds helps
Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We coordinate access to FDA-approved medicines: we help families and their treating physicians understand which route may apply, prepare the paperwork, and arrange compliant logistics once the regulator approves. We do not give medical advice, and every treatment decision belongs to the patient's physician and the regulator. Price: quote on request. Your coordination fee is quoted in writing for your case before you commit. No hidden charges.
Ask about a medicine on this list
Tell us the medicine and your country. We reply within one business day. On WhatsApp we usually reply the same day.
Frequently asked questions
What does this tracker show?
It lists 50 medicines approved by the US FDA between February 2024 and September 2026 and shows whether each one appeared in the Saudi SFDA drugs list and the Abu Dhabi DoH drug code list on 17 October 2026. Kuwait and Qatar are marked Not checked because we found no public searchable register.
If a medicine is "Not found" in Saudi Arabia, can a patient still get it?
Sometimes. A medicine that is not registered may still be imported for a named patient if the treating physician applies and the SFDA approves through its Named Patient Program or Special Access Program. The decision belongs to the SFDA, case by case.
Why does the UAE column use only the Abu Dhabi DoH list?
It was the only UAE list we could search in full on the date checked. The federal Emirates Drug Establishment online directory showed only eight sample entries, and we did not check Dubai. A medicine missing from the Abu Dhabi DoH list may still be registered federally or available in Dubai.
Why are Kuwait and Qatar marked "Not checked"?
We did not find a public, searchable drug register for Kuwait or Qatar. Rather than guess, we leave those columns as Not checked. Your hospital can confirm local status.
How current is this list?
Every row was checked on 17 October 2026, the date shown at the top. Registers change often, so a medicine marked Not found may be registered after that date. Always confirm with the regulator before acting.
Can Reserve Meds supply medicines that are not yet FDA-approved?
No. We coordinate access to FDA-approved medicines only. Investigational medicines are available only through the manufacturer's expanded access program, requested by the treating physician. We can explain that route, but we do not supply those medicines.
What does it cost?
Quote on request. We do not publish prices on this page. Your coordination fee is quoted in writing for your case before you commit. No hidden charges.
Sources
- US FDA, Novel Drug Approvals for 2024 (accessed 17 Oct 2026)
- US FDA, Novel Drug Approvals for 2025 (accessed 17 Oct 2026)
- US FDA, Novel Drug Approvals for 2026 (page current as of 9 Oct 2026; accessed 17 Oct 2026)
- US FDA CBER, 2024 Biological License Application Approvals (accessed 17 Oct 2026)
- US FDA CBER, 2025 Biological License Application Approvals (accessed 17 Oct 2026)
- US FDA CBER, 2026 Biological License Application Approvals (accessed 17 Oct 2026)
- US FDA, Approved Cellular and Gene Therapy Products (accessed 17 Oct 2026)
- US FDA press release, first gene therapy for Sanfilippo syndrome type A, 17 Sep 2026 (accessed 17 Oct 2026)
- Saudi Food and Drug Authority, Drugs List (9,173 entries downloaded 17 Oct 2026)
- Saudi Food and Drug Authority, scientific news (accessed 17 Oct 2026)
- Abu Dhabi Department of Health, drug code list (Drugs.xlsx), release 26 Sep 2026 (downloaded 17 Oct 2026)
- Emirates Drug Establishment, drug directory (only sample entries shown on 17 Oct 2026)
Important notice
This page is general information only. It is not medical advice, and it is not a statement about whether any medicine is right for any patient. Registers change often. Always confirm current status with the relevant regulator, your treating physician and the manufacturer. Medicine names and trademarks belong to their owners. Reserve Meds has no affiliation with the developers listed.
Reviewed by the Reserve Meds clinical operations team. Last reviewed . Editorial standards.
Related: Pending FDA decisions · Answers for Gulf families · Access guides · Drug catalog