Most FDA drug approvals since 2016
The companies with the most original approvals of new drug applications (NDAs) and biologics license applications (BLAs) from the Food and Drug Administration since January 2016, through Oct 16, 2026. Generic drugs (ANDAs) and supplements, such as new uses of approved drugs, are not counted. From Drugs@FDA.
Top 100
Click a column heading to sort. New molecular entities are NDAs for an active ingredient never approved before. Biologics are BLAs, including biosimilars. Orphan approvals treat rare diseases.
| # | Sponsor | Approvals | New molecular entities | Biologics | Orphan | Latest |
|---|---|---|---|---|---|---|
| 1 | Pfizer | 40 | 11 | 15 | 12 | HympavziOct 11, 2024 |
| 2 | AstraZeneca | 29 | 8 | 9 | 10 | Breztri AerosphereOct 8, 2026 |
| 3 | Azurity | 29 | 1 | 0 | 6 | LamliqueSep 25, 2026 |
| 4 | Novartis | 27 | 15 | 3 | 15 | RhapsidoSep 30, 2025 |
| 5 | Roche Holding | 25 | 4 | 16 | 11 | EvrysdiFeb 11, 2025 |
| 6 | Johnson & Johnson | 25 | 4 | 9 | 8 | IcotydeMar 17, 2026 |
| 7 | GSK | 24 | 9 | 6 | 5 | UtebziJun 17, 2026 |
| 8 | AbbVie | 24 | 7 | 4 | 13 | JuvmoSep 25, 2026 |
| 9 | Fresenius Kabi | 24 | 1 | 9 | 2 | GlycophosJul 29, 2026 |
| 10 | Teva Pharmaceutical Industries Ltd. | 23 | 1 | 4 | 3 | WeltruzaOct 8, 2026 |
| 11 | Merck & Co. | 22 | 10 | 6 | 5 | LipfendraJul 15, 2026 |
| 12 | Eli Lilly and Company | 20 | 8 | 10 | 4 | OnswikSep 23, 2026 |
| 13 | Gilead Sciences | 18 | 9 | 1 | 8 | BixlenvoAug 27, 2026 |
| 14 | Amgen | 18 | 1 | 14 | 6 | OtezlaAug 29, 2025 |
| 15 | Hikma Pharmaceuticals | 17 | 0 | 2 | 0 | EnobyOct 29, 2025 |
| 16 | Bristol-Myers Squibb | 16 | 9 | 5 | 10 | ZenbexusAug 13, 2026 |
| 17 | Sun Pharmaceutical | 16 | 2 | 1 | 1 | VobrigAug 26, 2026 |
| 18 | Celltrion | 14 | 0 | 14 | 0 | AvtozmaJan 21, 2026 |
| 19 | Baxter International | 14 | 0 | 1 | 0 | Sodium BicarbonateAug 14, 2026 |
| 20 | Samsung Bioepis | 14 | 0 | 14 | 0 | EpysqliNov 28, 2025 |
| 21 | Takeda Pharmaceutical Company | 13 | 7 | 2 | 6 | MimryloAug 28, 2026 |
| 22 | Viatris | 13 | 2 | 5 | 1 | Gwyn LoJul 28, 2026 |
| 23 | Sanofi | 12 | 3 | 9 | 7 | Sarclisa EscenaJul 9, 2026 |
| 24 | Avyxa Holdings | 12 | 0 | 0 | 0 | NavitruxJun 24, 2026 |
| 25 | Bayer | 11 | 8 | 0 | 6 | AmbelvistJun 12, 2026 |
| 26 | Bausch & Lomb | 10 | 3 | 0 | 0 | Lumify Preservative FreeApr 19, 2024 |
| 27 | Exela Pharma | 10 | 0 | 0 | 0 | Fentanyl CitrateFeb 8, 2023 |
| 28 | UCB | 9 | 3 | 2 | 5 | KygevviNov 3, 2025 |
| 29 | Mayne Pharma | 9 | 3 | 0 | 0 | EpsolayApr 22, 2022 |
| 30 | Boehringer Ingelheim | 9 | 2 | 2 | 3 | JascaydDec 19, 2025 |
| 31 | Amneal Pharmaceuticals, Inc. | 9 | 1 | 3 | 0 | Sodium BicarbonateJul 9, 2026 |
| 32 | Accord Hlthcare | 9 | 0 | 0 | 0 | BortezomibJul 26, 2022 |
| 33 | Sandoz | 9 | 0 | 7 | 0 | EnzeevuAug 9, 2024 |
| 34 | Almatica | 9 | 0 | 0 | 0 | Duloxetine HydrochlorideFeb 27, 2026 |
| 35 | Biogen | 8 | 4 | 3 | 3 | TofidenceSep 29, 2023 |
| 36 | Alcon | 8 | 3 | 0 | 0 | BrytlyOct 16, 2026 |
| 37 | Astellas Pharma | 8 | 3 | 2 | 3 | VyloyOct 18, 2024 |
| 38 | Novo | 7 | 3 | 2 | 1 | WegovyDec 22, 2025 |
| 39 | Bracco | 7 | 2 | 0 | 0 | Isovue ReadiOct 9, 2026 |
| 40 | BeOne Medicines Ltd. | 7 | 2 | 3 | 7 | BeqalziMay 13, 2026 |
| 41 | Bausch Health | 7 | 1 | 1 | 0 | CabtreoOct 20, 2023 |
| 42 | Regeneron Pharmaceuticals | 7 | 0 | 7 | 4 | PasatruAug 19, 2026 |
| 43 | CMP Dev LLC | 7 | 0 | 0 | 1 | QlonilikJul 29, 2026 |
| 44 | Biocon | 7 | 0 | 7 | 0 | AukelsoOct 29, 2025 |
| 45 | Vertex Pharmaceuticals | 6 | 4 | 0 | 5 | JournavxJan 30, 2025 |
| 46 | Accord Biopharma Inc. | 6 | 0 | 6 | 0 | ImmgolisMay 15, 2026 |
| 47 | Jazz Pharmaceuticals | 5 | 2 | 2 | 5 | ZiiheraNov 20, 2024 |
| 48 | Otsuka Pharmaceutical | 5 | 2 | 1 | 1 | SimtriyoJul 24, 2026 |
| 49 | Sumitomo Pharma | 5 | 2 | 0 | 0 | MyfembreeMay 26, 2021 |
| 50 | Daiichi Sankyo | 5 | 2 | 3 | 3 | DatrowayJun 23, 2025 |
| 51 | Incyte | 5 | 2 | 2 | 4 | Jakafi XRMay 1, 2026 |
| 52 | HQ SPCLT Pharma | 5 | 0 | 0 | 0 | Diltiazem Hydrochloride in 0.72% Sodium ChlorideFeb 21, 2025 |
| 53 | Harrow Eye | 5 | 0 | 0 | 1 | ByqloviMar 4, 2024 |
| 54 | Am Regent | 5 | 0 | 0 | 0 | PaclitaxelJul 27, 2022 |
| 55 | Maia Pharms Inc | 5 | 0 | 0 | 0 | DaptomycinNov 21, 2024 |
| 56 | Novo | 5 | 0 | 4 | 3 | Awiqli FlextouchMar 26, 2026 |
| 57 | Shorla | 5 | 0 | 0 | 0 | TepyluteJun 25, 2024 |
| 58 | Rigel Pharmaceuticals Inc | 4 | 4 | 0 | 3 | VeppanuMay 1, 2026 |
| 59 | Alnylam Pharmaceuticals | 4 | 4 | 0 | 4 | AmvuttraJun 13, 2022 |
| 60 | Shionogi | 4 | 3 | 0 | 2 | XocovaMay 29, 2026 |
| 61 | Vanda Pharmaceuticals Inc. | 4 | 3 | 0 | 1 | BysantiFeb 20, 2026 |
| 62 | Acadia Pharmaceuticals | 4 | 2 | 0 | 2 | Daybue StixDec 11, 2025 |
| 63 | Neurocrine Biosciences | 4 | 2 | 0 | 4 | CrenessityDec 13, 2024 |
| 64 | Alkermes | 4 | 2 | 0 | 1 | LumryzMay 1, 2023 |
| 65 | Mirum Pharmaceuticals | 4 | 2 | 0 | 4 | AtebriozSep 25, 2026 |
| 66 | Phathom Pharmaceuticals, Inc. | 4 | 2 | 0 | 0 | VoqueznaJul 17, 2024 |
| 67 | Acrotech Biopharma | 4 | 1 | 0 | 2 | AdqueyFeb 12, 2026 |
| 68 | Heron Theraps Inc | 4 | 1 | 0 | 0 | AponvieSep 16, 2022 |
| 69 | Merck KGaA | 4 | 1 | 2 | 2 | TepmetkoFeb 3, 2021 |
| 70 | Galderma Group AG | 4 | 1 | 2 | 0 | Differin Epiduo Acne Gel (adapalene and Benzoyl Peroxide)May 22, 2026 |
| 71 | Chiesi | 4 | 1 | 0 | 3 | TrimbowMay 14, 2026 |
| 72 | GLAUKOS Corp | 4 | 0 | 0 | 3 | Epioxa Hd/Epioxa KitOct 17, 2025 |
| 73 | Dexcel | 4 | 0 | 0 | 1 | Esomeprazole MagnesiumOct 20, 2020 |
| 74 | PH Health | 4 | 0 | 0 | 0 | AdrenalinApr 21, 2023 |
| 75 | Cycle | 4 | 0 | 0 | 2 | CavhanzaMay 29, 2026 |
| 76 | Lupin Ltd. | 4 | 0 | 2 | 0 | RanluspecJun 2, 2026 |
| 77 | B Braun Medical | 4 | 0 | 0 | 0 | Rocuronium BromideOct 24, 2025 |
| 78 | Journey Medical Corp | 4 | 0 | 0 | 0 | EmrosiNov 1, 2024 |
| 79 | DR Reddys Labs Sa | 4 | 0 | 1 | 1 | ZimrixbyJul 31, 2026 |
| 80 | Sarepta Theraps Inc | 3 | 3 | 0 | 3 | Amondys 45Feb 25, 2021 |
| 81 | PTC Therapeutics | 3 | 3 | 0 | 3 | SephienceJul 28, 2025 |
| 82 | LNHC | 3 | 3 | 0 | 0 | ZelsuvmiJan 5, 2024 |
| 83 | Sentynl Theraps Inc | 3 | 3 | 0 | 3 | ZycuboJan 12, 2026 |
| 84 | Ipsen | 3 | 3 | 0 | 3 | IqirvoJun 10, 2024 |
| 85 | Ionis Pharmaceuticals Inc | 3 | 3 | 0 | 3 | ZanvastroSep 3, 2026 |
| 86 | Almirall | 3 | 2 | 0 | 0 | KlisyriDec 14, 2020 |
| 87 | Catalyst Pharmaceuticals | 3 | 2 | 0 | 2 | AgamreeOct 26, 2023 |
| 88 | Paratek Pharmaceuticals, Inc. | 3 | 2 | 0 | 0 | NuzyraOct 2, 2018 |
| 89 | Springworks | 3 | 2 | 0 | 3 | GomekliFeb 11, 2025 |
| 90 | Tersera | 3 | 1 | 0 | 1 | Qmiiz OdtOct 19, 2018 |
| 91 | BioMarin Pharmaceutical | 3 | 1 | 2 | 3 | VoxzogoNov 19, 2021 |
| 92 | Supernus Pharmaceuticals, INC. | 3 | 1 | 0 | 1 | QelbreeApr 2, 2021 |
| 93 | Kyowa Kirin | 3 | 1 | 2 | 2 | NourianzAug 27, 2019 |
| 94 | Amicus Therapeutics | 3 | 1 | 1 | 3 | OpfoldaSep 28, 2023 |
| 95 | Cosette | 3 | 1 | 0 | 0 | Vyleesi (autoinjector)Jun 21, 2019 |
| 96 | Eisai | 3 | 1 | 2 | 0 | Leqembi IqlikAug 29, 2025 |
| 97 | Provepharm Sas | 3 | 0 | 0 | 1 | ZyogreenJul 10, 2026 |
| 98 | Ferring Pharmaceuticals | 3 | 0 | 0 | 0 | MilprosaApr 29, 2020 |
| 99 | Indivior | 3 | 0 | 0 | 1 | OpveeMay 22, 2023 |
| 100 | Scilex Pharms | 3 | 0 | 0 | 0 | ElyxybMay 5, 2020 |
Showing the top 100 of 578. Download all 578 as CSV.
Source: openFDA Drugs@FDA. Sponsors are matched to companies where we can (Janssen to Johnson & Johnson, Genentech to Roche); others appear under the name the FDA gives. Each latest approval links to its Drugs@FDA page.