Drug approvals worldwide
Which new molecules were approved first, and where: the FDA, the EMA and Health Canada side by side, with the biosimilar, orphan and safety registers that go with them.
In the last 12 months, 63 substances received their first approval from the FDA, the EMA or Health Canada: 51 in the US first, 6 in the EU first and 6 in Canada first. For molecules approved in both the US and the EU since 2021, the EU authorisation came a median of 154 days after the FDA's, and the EU was first for 27% of them. Dates are each regulator's first listed approval of a product containing only that substance. Most are new molecules; a few are long-used substances receiving their first formal approval.
Substances approved for the first time in the last 12 months
63 substances| Molecule | United States | European Union | Canada |
|---|---|---|---|
| Denecimig Frehemgo |
Not yet | Not yet | 2 Oct 2026 First Frehemgo |
| Zilurgisertib Atebrioz |
25 Sep 2026 First Atebrioz |
Not yet | Not yet |
| Tavapadon Juvmo |
25 Sep 2026 First Juvmo |
Not yet | Not yet |
| 18f Psma 1007 Prostalumin |
Not yet | Not yet | 24 Sep 2026 First Prostalumin |
| Lirafugratinib Lyrfigtu |
23 Sep 2026 First Lyrfigtu |
Not yet | Not yet |
| Insulin Efsitora Alfa Onswik |
23 Sep 2026 First Onswik |
Not yet | Not yet |
| Leriglitazone Nezglyal |
Not yet | 21 Sep 2026 First Nezglyal |
Not yet |
| Floretyrosine F 18 Pixclara |
11 Sep 2026 First Pixclara |
Not yet | Not yet |
| Apitegromab Isembyld |
11 Sep 2026 First Isembyld |
Not yet | Not yet |
| Zilganersen Zanvastro |
3 Sep 2026 First Zanvastro |
Not yet | Not yet |
| Rusfertide Mimrylo |
28 Aug 2026 First Mimrylo |
Not yet | Not yet |
| Brepocitinib Lisraya |
27 Aug 2026 First Lisraya |
Not yet | Not yet |
| Daraxonrasib Rasonque |
26 Aug 2026 First Rasonque |
Not yet | Not yet |
| Garetosmab Pasatru |
19 Aug 2026 First Pasatru |
Not yet | Not yet |
| Florquinitau F 18 Tauklarify |
13 Aug 2026 First Tauklarify |
Not yet | Not yet |
| Iberdomide Zenbexus |
13 Aug 2026 First Zenbexus |
Not yet | Not yet |
| Oveporexton Orzeyful |
5 Aug 2026 First Orzeyful |
Not yet | Not yet |
| Sodium Glycerophosphate Glycophos |
29 Jul 2026 First Glycophos |
Not yet | Not yet |
| Centanafadine Simtriyo |
24 Jul 2026 First Simtriyo |
Not yet | Not yet |
| Zidesamtinib Jideytro |
22 Jul 2026 First Jideytro |
Not yet | Not yet |
| Camizestrant Etcamah |
4 Sep 2026 Etcamah |
20 Jul 2026 First Etcamah |
4 Aug 2026 Etcamah |
| Enlicitide Decanoate Lipfendra |
15 Jul 2026 First Lipfendra |
Not yet | Not yet |
| Gedatolisib Revtorpyk |
14 Jul 2026 First Revtorpyk |
Not yet | Not yet |
| Atacicept Trutakna |
7 Jul 2026 First Trutakna |
Not yet | Not yet |
| Veligrotug Lumvoa |
26 Jun 2026 First Lumvoa |
Not yet | Not yet |
| Chikungunya Virus Virus Like Particle Vimkunya |
Not yet | Not yet | 26 Jun 2026 First Vimkunya |
| Trenibotulinumtoxine Boey |
Not yet | 15 Jul 2026 Boey |
22 Jun 2026 First Boey |
| Tolebrutinib Cenrifki |
Not yet | 19 Jun 2026 First Cenrifki |
Not yet |
| Tebipenem Pivoxil Utebzi |
17 Jun 2026 First Utebzi |
Not yet | Not yet |
| Gadoquatrane Ambelvist |
12 Jun 2026 First Ambelvist |
Not yet | 29 Jul 2026 Ambelvist |
| Pimicotinib Pimjetmi |
Not yet | Not yet | 12 Jun 2026 First Pimjetmi |
| Ensitrelvir Xocova |
29 May 2026 First Xocova |
18 Sep 2026 Zokovea |
Not yet |
| Cipepofol Cypsedo |
29 May 2026 First Cypsedo |
Not yet | Not yet |
| Pivekimab Sunirine Decnupaz |
27 May 2026 First Decnupaz |
Not yet | Not yet |
| Adapalene Benzoyl Peroxide Differin Epiduo Acne Gel (adapalene And Benzoyl Peroxide) |
22 May 2026 First Differin Epiduo Acne Gel (adapalene And Benzoyl Peroxide) |
Not yet | Not yet |
| Baxdrostat Baxfendy |
15 May 2026 First Baxfendy |
Not yet | Not yet |
| Sonrotoclax Beqalzi |
13 May 2026 First Beqalzi |
Not yet | Not yet |
| Vepdegestrant Veppanu |
1 May 2026 First Veppanu |
Not yet | Not yet |
| Orforglipron Foundayo |
1 Apr 2026 First Foundayo |
Not yet | Not yet |
| Estetrol Fylrevy |
Not yet | 26 Mar 2026 First Fylrevy |
Not yet |
| Relacorilant Lifyorli (copackaged) |
25 Mar 2026 First Lifyorli (copackaged) |
Not yet | Not yet |
| Tividenofusp Alfa Avlayah |
24 Mar 2026 First Avlayah |
Not yet | Not yet |
| Icotrokinra Icotyde |
17 Mar 2026 First Icotyde |
18 Sep 2026 Icotyde |
Not yet |
| Linerixibat Lynavoy |
17 Mar 2026 First Lynavoy |
Not yet | Not yet |
| Nadofaragene Firadenovec Adstiladrin |
Not yet | 28 May 2026 Adstiladrin |
16 Mar 2026 First Adstiladrin |
| Navepegritide Yuviwel |
27 Feb 2026 First Yuviwel |
Not yet | Not yet |
| Milsaperidone Bysanti |
20 Feb 2026 First Bysanti |
Not yet | Not yet |
| Difamilast Adquey |
12 Feb 2026 First Adquey |
Not yet | Not yet |
| Air Air |
2 Feb 2026 First Air |
Not yet | Not yet |
| L Acetylleucine Aqneursa |
Not yet | 19 Jan 2026 First Aqneursa |
Not yet |
| Copper Histidinate Zycubo |
12 Jan 2026 First Zycubo |
Not yet | Not yet |
| Etuvetidigene Autotemcel Waskyra |
Not yet | 9 Jan 2026 First Waskyra |
Not yet |
| Tradipitant Nereus |
30 Dec 2025 First Nereus |
Not yet | Not yet |
| Narsoplimab Yartemlea |
23 Dec 2025 First Yartemlea |
Not yet | Not yet |
| Aficamten Myqorzo |
19 Dec 2025 First Myqorzo |
12 Feb 2026 Myqorzo |
Not yet |
| Depemokimab Exdensur |
16 Dec 2025 First Exdensur |
12 Feb 2026 Exdensur |
15 Jun 2026 Exdensur |
| Zoliflodacin Nuzolvence |
12 Dec 2025 First Nuzolvence |
Not yet | Not yet |
| Etripamil Cardamyst |
12 Dec 2025 First Cardamyst |
Not yet | Not yet |
| Lerodalcibep Lerochol |
12 Dec 2025 First Lerochol |
Not yet | Not yet |
| Sibeprenlimab Voyxact |
25 Nov 2025 First Voyxact |
Not yet | Not yet |
| Sevabertinib Hyrnuo |
19 Nov 2025 First Hyrnuo |
Not yet | 29 Jan 2026 Hyrnuo |
| Plozasiran Redemplo |
18 Nov 2025 First Redemplo |
19 Jun 2026 Redemplo |
2 Jan 2026 Redemplo |
| Ziftomenib Komzifti |
13 Nov 2025 First Komzifti |
Not yet | Not yet |
"Not yet" means no approval appears in that regulator's register. US data covers drugs and CDER biologics in Drugs@FDA (vaccines and gene therapies licensed by CBER are not included); EU data covers centralised authorisations only; Canadian data covers new-drug Notices of Compliance since 1994.
Approvals and safety registers
How this page is built
Every date is copied from the three regulators' own registers.
- Drugs@FDA via openFDA ↗ first original approval date, brand name and application number of every NDA and BLA
- EMA medicines data ↗ first centralised marketing authorisation of each active substance (originator products only)
- Health Canada Notice of Compliance (NOC) API ↗ first new-drug Notice of Compliance for each ingredient. Contains information licensed under the Open Government Licence - Canada
A nightly job downloads each register, keeps approvals of products that contain a single active substance, normalises substance names (salts removed) and records the earliest approval per substance and regulator. Generics and biosimilars are excluded from the EU first-approval date. No AI drafting and no editorial pass. See our editorial standards. The the regulators data on this page was last retrieved on 12 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.