Ankylosing Spondylitis
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Sign up freeTop drugs studied for this disease
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EMA approval · 2025-12-15EMA Authorised: Remicade (infliximab) — Janssen Cilag International NV
The EMA has authorised Remicade (infliximab) for multiple inflammatory diseases under Janssen Cilag International NV as the marketing author…
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EMA approval · 2025-12-11EMA Authorised: Hyrimoz (adalimumab) — Sandoz GmbH
EMA authorised Hyrimoz (adalimumab) by Sandoz GmbH as a biosimilar to Humira for multiple inflammatory diseases, including rheumatoid arthri…
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EMA approval · 2025-11-10EMA Authorised: Flixabi (infliximab) — Samsung Bioepis NL B.V.
The EMA authorised Flixabi, a biosimilar of infliximab, for several inflammatory diseases. The indications include rheumatoid arthritis, pso…
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FDA approval · 2025-10-28FDA Approved: RENFLEXIS — Supplemental Application (Organon LLC)
FDA approved a supplemental application for RENFLEXIS (infliximab) submitted by Organon LLC. The approval updates the product labeling to re…
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EMA approval · 2025-10-22EMA Authorised: Amsparity (adalimumab) — Pfizer Europe MA EEIG
EMA authorised Amsparity (adalimumab) from Pfizer Europe MA EEIG. The biosimilar is approved for multiple autoimmune indications including r…
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EMA approval · 2025-10-21EMA Authorised: Idacio (adalimumab) — Fresenius Kabi Deutschland GmbH
EMA authorised Idacio, a biosimilar of adalimumab, for multiple inflammatory diseases, produced by Fresenius Kabi Deutschland GmbH. The indi…
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FDA approval · 2025-10-17FDA Approved: HADLIMA — Supplemental Application (Organon LLC)
FDA approved a supplemental application for HADLIMA (adalimumab-bwwd) from Organon LLC, supporting expanded indications for this adalimumab …
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FDA approval · 2025-10-16FDA Approved: AMJEVITA — Supplemental Application (Nuvaila Limited)
FDA approved a supplemental application for Amjevita (adalimumab-atto) submitted by Nuvaila Limited.
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EMA approval · 2025-10-08EMA Authorised: Humira (adalimumab) — AbbVie Deutschland GmbH & Co. KG
The EMA authorised Humira (adalimumab) by AbbVie Deutschland GmbH & Co. KG for multiple indications including ankylosing spondylitis, juveni…
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FDA approval · 2025-10-03FDA Approved: NAPROXEN — Original Application (Aurobindo Pharma Limited)
FDA approved Naproxen from Aurobindo Pharma Limited as an original generic application (ANDA 216504). Naproxen is a nonsteroidal anti-inflam…
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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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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 · 2025-06-24EMA 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 · 2025-06-05FDA 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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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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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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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…
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FDA approval · 2025-02-15FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Naproxen (ANDA074190) from Hikma Pharmaceuticals USA Inc., resulting in an updated approval of t…