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:

اقرأ هذه الصفحة بالعربية

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.

50FDA approvals tracked
35not found in either list
46not found in the SFDA list
36not found in the Abu Dhabi DoH list

"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

50 FDA approvals and their status in the Saudi SFDA drugs list and the Abu Dhabi DoH drug code list, checked 17 October 2026
EmcitatetiratricolRare Thyroid Therapeutics28 Sep 2026MCT8 deficiency (Allan-Herndon-Dudley syndrome)Not foundNot foundNot checkedNot checked
AtebriozzilurgisertibMirum Pharmaceuticals25 Sep 2026Fibrodysplasia ossificans progressivaNot foundNot foundNot checkedNot checked
LyrfigtulirafugratinibElevar Therapeutics23 Sep 2026FGFR2-rearranged cholangiocarcinomaNot foundNot foundNot checkedNot checked
Fayuvirebisufligene etisparvovecUltragenyx17 Sep 2026Sanfilippo syndrome type A (MPS IIIA) in children (gene therapy)Not foundNot foundNot checkedNot checked
IsembyldapitegromabScholar Rock11 Sep 2026SMA, age 2 and older, added to SMN2-targeted treatmentNot foundNot foundNot checkedNot checked
ZanvastrozilganersenIonis3 Sep 2026Alexander diseaseNot foundNot foundNot checkedNot checked
RasonquedaraxonrasibRevolution Medicines26 Aug 2026Metastatic pancreatic cancerNot foundListedNot checkedNot checked
Genglycospariglasgene brecaparvovecUltragenyx19 Aug 2026Glycogen storage disease type Ia (gene therapy)Not foundNot foundNot checkedNot checked
ZenbexusiberdomideBristol Myers Squibb13 Aug 2026Multiple myeloma after at least one prior line, with daratumumab and dexamethasoneListedNot foundNot checkedNot checked
Tudriqevvusolimogene oderparepvecReplimune6 Aug 2026Advanced melanoma after PD-1 therapy, with nivolumab (oncolytic virus)Not foundNot foundNot checkedNot checked
Decnupazpivekimab sunirineAbbVie27 May 2026Blastic plasmacytoid dendritic cell neoplasmNot foundNot foundNot checkedNot checked
BeqalzisonrotoclaxBeOne Medicines13 May 2026Relapsed or refractory mantle cell lymphomaNot foundNot foundNot checkedNot checked
Otarmenilunsotogene parvecRegeneron23 Apr 2026OTOF-related severe hearing loss (gene therapy)Not foundNot foundNot checkedNot checked
Kresladimarnetegragene autotemcelRocket Pharmaceuticals26 Mar 2026Severe leukocyte adhesion deficiency-I (gene therapy)Not foundNot foundNot checkedNot checked
Avlayahtividenofusp alfaDenali Therapeutics24 Mar 2026Hunter syndrome (MPS II)Not foundNot foundNot checkedNot checked
LoargyspegzilarginaseImmedica23 Feb 2026Arginase 1 deficiencyNot foundListedNot checkedNot checked
Zycubocopper histidinateSentynl Therapeutics12 Jan 2026Menkes diseaseNot foundNot foundNot checkedNot checked
YartemleanarsoplimabOmeros23 Dec 2025Transplant-associated thrombotic microangiopathyNot foundNot foundNot checkedNot checked
Waskyraetuvetidigene autotemcelFondazione Telethon9 Dec 2025Wiskott-Aldrich syndrome (gene therapy)Not foundNot foundNot checkedNot checked
Itvismaonasemnogene abeparvovec-brveNovartis Gene Therapies24 Nov 2025SMA, age 2 and older (intrathecal gene therapy)Not foundListedNot checkedNot checked
KomziftiziftomenibKura Oncology13 Nov 2025Relapsed or refractory NPM1-mutant AMLNot foundNot foundNot checkedNot checked
Kygevvidoxecitine and doxribtimineUCB3 Nov 2025Thymidine kinase 2 deficiencyNot foundNot foundNot checkedNot checked
ForzinityelamipretideStealth BioTherapeutics19 Sep 2025Barth syndromeNot foundNot foundNot checkedNot checked
Papzimeoszopapogene imadenovecPrecigen14 Aug 2025Recurrent respiratory papillomatosis (gene therapy)Not foundNot foundNot checkedNot checked
ModeysodordaviproneChimerix (Jazz)6 Aug 2025H3 K27M-mutant diffuse midline gliomaNot foundListedNot checkedNot checked
LynozyficlinvoseltamabRegeneron2 Jul 2025Relapsed or refractory multiple myeloma after 4 or more prior linesNot foundNot foundNot checkedNot checked
ZegfrovysunvozertinibDizal2 Jul 2025NSCLC with EGFR exon 20 insertionNot foundNot foundNot checkedNot checked
Avmapki Fakzynja Co-Packavutometinib and defactinibVerastem8 May 2025KRAS-mutated recurrent low-grade serous ovarian cancerNot foundNot foundNot checkedNot checked
Zevaskynprademagene zamikeracelAbeona Therapeutics28 Apr 2025Wounds in recessive dystrophic epidermolysis bullosa (gene-corrected cell sheets)Not foundNot foundNot checkedNot checked
QfitliafitusiranGenzyme (Sanofi)28 Mar 2025Hemophilia A or B prophylaxisListedListedNot checkedNot checked
RomvimzavimseltinibDeciphera14 Feb 2025Tenosynovial giant cell tumorNot foundNot foundNot checkedNot checked
GomeklimirdametinibSpringWorks Therapeutics11 Feb 2025NF1 plexiform neurofibromasNot foundListedNot checkedNot checked
Datrowaydatopotamab deruxtecanDaiichi Sankyo17 Jan 2025HR-positive, HER2-negative breast cancerNot foundListedNot checkedNot checked
TryngolzaolezarsenIonis19 Dec 2024Familial chylomicronemia syndromeNot foundListedNot checkedNot checked
Ryoncilremestemcel-LMesoblast18 Dec 2024Steroid-refractory acute GvHD in children (cell therapy)Not foundNot foundNot checkedNot checked
BizengrizenocutuzumabMerus4 Dec 2024NRG1 fusion-positive lung and pancreatic cancerNot foundNot foundNot checkedNot checked
ZiiherazanidatamabJazz Pharmaceuticals20 Nov 2024HER2-positive biliary tract cancerNot foundNot foundNot checkedNot checked
RevuforjrevumenibSyndax15 Nov 2024Relapsed or refractory acute leukemia with KMT2A translocationNot foundListedNot checkedNot checked
Kebilidieladocagene exuparvovecPTC Therapeutics13 Nov 2024AADC deficiency (gene therapy)Not foundNot foundNot checkedNot checked
Aucatzylobecabtagene autoleucelAutolus8 Nov 2024Relapsed or refractory adult B-cell ALL (CAR-T)Not foundNot foundNot checkedNot checked
AqneursalevacetylleucineIntraBio24 Sep 2024Niemann-Pick disease type CNot foundListedNot checkedNot checked
MiplyffaarimoclomolZevra Therapeutics20 Sep 2024Niemann-Pick disease type CNot foundNot foundNot checkedNot checked
VoranigovorasidenibServier6 Aug 2024Grade 2 IDH-mutant astrocytoma or oligodendrogliomaListedListedNot checkedNot checked
Tecelraafamitresgene autoleucelAdaptimmune1 Aug 2024Synovial sarcoma, MAGE-A4 positive (engineered T-cell therapy)Not foundNot foundNot checkedNot checked
ImdelltratarlatamabAmgen16 May 2024Extensive-stage small cell lung cancerListedListedNot checkedNot checked
Beqvezfidanacogene elaparvovecPfizer25 Apr 2024Moderate to severe hemophilia B (gene therapy)Not foundNot foundNot checkedNot checked
OjemdatovorafenibDay One Biopharmaceuticals23 Apr 2024Relapsed or refractory pediatric low-grade gliomaNot foundListedNot checkedNot checked
DuvyzatgivinostatItalfarmaco21 Mar 2024Duchenne muscular dystrophy, age 6 and olderNot foundListedNot checkedNot checked
Lenmeldyatidarsagene autotemcelOrchard Therapeutics18 Mar 2024Metachromatic leukodystrophy, early-onset forms (gene therapy)Not foundNot foundNot checkedNot checked
AmtagvilifileucelIovance Biotherapeutics16 Feb 2024Unresectable or metastatic melanoma after PD-1 therapy (cell therapy)Not foundNot foundNot checkedNot 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.

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No account needed. We reply within one business day. Your coordination fee is quoted in writing for your case before you commit. No hidden charges.

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

  1. US FDA, Novel Drug Approvals for 2024 (accessed 17 Oct 2026)
  2. US FDA, Novel Drug Approvals for 2025 (accessed 17 Oct 2026)
  3. US FDA, Novel Drug Approvals for 2026 (page current as of 9 Oct 2026; accessed 17 Oct 2026)
  4. US FDA CBER, 2024 Biological License Application Approvals (accessed 17 Oct 2026)
  5. US FDA CBER, 2025 Biological License Application Approvals (accessed 17 Oct 2026)
  6. US FDA CBER, 2026 Biological License Application Approvals (accessed 17 Oct 2026)
  7. US FDA, Approved Cellular and Gene Therapy Products (accessed 17 Oct 2026)
  8. US FDA press release, first gene therapy for Sanfilippo syndrome type A, 17 Sep 2026 (accessed 17 Oct 2026)
  9. Saudi Food and Drug Authority, Drugs List (9,173 entries downloaded 17 Oct 2026)
  10. Saudi Food and Drug Authority, scientific news (accessed 17 Oct 2026)
  11. Abu Dhabi Department of Health, drug code list (Drugs.xlsx), release 26 Sep 2026 (downloaded 17 Oct 2026)
  12. 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

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