Rheumatoid Arthritis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-09-17FDA Approved: AMJEVITA — Supplemental Application (Nuvaila Limited)
The FDA approved a supplemental BLA for AMJEVITA (adalimumab-atto) submitted by Nuvaila Limited. The action concerns regulatory approval rel…
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FDA approval · 2025-09-03FDA Approved: INFLECTRA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved a supplemental application for Inflectra (infliximab-dyyb) from Pfizer to update its labeling and/or indications, following…
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EMA approval · 2025-08-13EMA Authorised: Enbrel (etanercept) — Pfizer Europe MA EEIG
The European Medicines Agency authorised Enbrel (etanercept) for multiple inflammatory diseases including rheumatoid arthritis, ankylosing s…
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EMA approval · 2025-08-05EMA Authorised: Riximyo (rituximab) — Sandoz GmbH
EMA authorized the biosimilar Riximyo (rituximab) by Sandoz GmbH for multiple indications, including Non-Hodgkin lymphoma, rheumatoid arthri…
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FDA approval · 2025-07-29FDA Approved: ADALIMUMAB — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for Sandoz Inc for the adalimumab biosimilar ADALIMUMAB-ADAZ, enabling its use with indications cons…
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FDA approval · 2025-07-29FDA Approved: VYSCOXA — Original Application (Carwin Pharmaceutical Associates, LLC)
FDA approved VYSCOXA, a brand name for celecoxib, under Carwin Pharmaceutical Associates, LLC's original application. This confirms marketin…
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EMA approval · 2025-07-17EMA Authorised: Nordimet (methotrexate) — Nordic Group B.V.
EMA authorised Nordimet (methotrexate) by Nordic Group B.V. for use in arthritis-related conditions including rheumatoid arthritis, psoriati…
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EMA approval · 2025-07-14EMA Authorised: Ruxience (rituximab) — Pfizer Europe MA EEIG
The EMA authorised Ruxience, a rituximab biosimilar by Pfizer Europe MA EEIG, for several indications including chronic lymphocytic leukemia…
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EMA approval · 2025-07-09EMA Authorised: Ituxredi (rituximab) — Reddy Holding GmbH
The EMA authorised Ituxredi (rituximab) by Reddy Holding GmbH. It is indicated for non-Hodgkin lymphoma, chronic lymphocytic leukemia, and r…
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EMA approval · 2025-06-24EMA Authorised: Zessly (infliximab) — Sandoz GmbH
EMA authorised Zessly (infliximab) from Sandoz GmbH as a biosimilar for treatment of several inflammatory diseases, including rheumatoid art…
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FDA approval · 2025-06-13FDA Approved: HYDROXYCHLOROQUINE — Supplemental Application (Chartwell RX, LLC)
The FDA approved a supplemental application for hydroxychloroquine (HYDROXYCHLOROQUINE) from Chartwell RX, LLC under an ANDA. The action upd…
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FDA approval · 2025-06-13FDA Approved: AZATHIOPRINE — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved a supplemental application for azathioprine from Ascend Laboratories, LLC.
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EMA approval · 2025-06-10EMA Authorised: Jyseleca (filgotinib maleate) — Alfasigma S.p.A.
EMA authorised Jyseleca (filgotinib maleate) for rheumatoid arthritis; decision date 02/06/2025; MAH is Alfasigma S.p.A.
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FDA approval · 2025-06-05FDA Approved: XIFYRM — Original Application (Azurity Pharmaceuticals, Inc.)
FDA approved XIFYRM (meloxicam) under an original application by Azurity Pharmaceuticals, Inc., establishing a new branded meloxicam product…
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EMA approval · 2025-05-19EMA Authorised: Orencia (abatacept) — Bristol-Myers Squibb Pharma EEIG
The EMA authorised Orencia (abatacept) by Bristol-Myers Squibb Pharma EEIG for rheumatoid arthritis, psoriatic arthritis, and juvenile idiop…
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FDA approval · 2025-05-12FDA Approved: TYENNE — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for TYENNE (tocilizumab-azg) from Fresenius Kabi USA, LLC.
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FDA approval · 2025-04-07FDA Approved: ADALIMUMAB — Supplemental Application (CELLTRION USA, Inc.)
FDA approved a supplemental application for ADALIMUMAB-AATY, a biosimilar adalimumab from Celltrion USA, Inc., in connection with its regula…
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EMA approval · 2025-04-03EMA Authorised: MabThera (rituximab) — Roche Registration GmbH
EMA authorised MabThera (rituximab) for multiple indications including Non-Hodgkin lymphoma, rheumatoid arthritis, and chronic lymphocytic l…
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FDA approval · 2025-03-26FDA Approved: RINVOQ — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for Rinvoq (upadacitinib) from AbbVie, resulting in labeling changes to the product.
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FDA approval · 2025-03-21FDA Approved: NAPROXEN AND ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for Naproxen and Esomeprazole Magnesium from Dr. Reddy's Laboratories Limited. This approval confirm…
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FDA approval · 2025-03-13FDA Approved: TYENNE — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for TYENNE (tocilizumab-AAZG) from Fresenius Kabi USA, LLC.
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EMA approval · 2025-03-03EMA Authorised: Nepexto (etanercept) — Biosimilar Collaborations Ireland Limited
EMA authorised Nepexto, a biosimilar of etanercept, developed by Biosimilar Collaborations Ireland Limited, for several inflammatory arthrit…
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FDA approval · 2025-02-27FDA Approved: DICLOFENAC SODIUM/MISOPROSTOL DICLOFENAC-SODIUM-MISOPROSTOL — Supplemental Application (Micro Labs Limited)
FDA approved a supplemental application for Diclofenac Sodium/Misoprostol (Diclofenac-Sodium-Misoprostol) from Micro Labs Limited.
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FDA approval · 2025-02-26FDA Approved: CELECOXIB — Supplemental Application (Apotex Corp.)
FDA approved Apotex Corp.'s supplemental application for Celecoxib (celecoxib), authorizing a generic version under the ANDA pathway. The ac…
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FDA approval · 2025-02-24FDA Approved: INDOMETHACIN — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved Amneal Pharmaceuticals NY LLC's original application for Indomethacin, authorizing a generic version of the NSAID with the same…