Psoriatic Arthritis

• FDA approval · 2025-02-12
  FDA Approved: SELARSDI — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for SELARSDI (ustekinumab-aeKn) from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2024-12-26
  FDA Approved: WEZLANA — Supplemental Application (Nuvaila Limited)

  The FDA approved a supplemental Biologics License Application for WEZLANA (ustekinumab-auub) submitted by Nuvaila Limited.

• FDA approval · 2024-12-20
  FDA Approved: USTEKINUMAB-TTWE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for USTEKINUMAB-TTWE from Quallent Pharmaceuticals Health LLC. This action confirms additional regul…

• FDA approval · 2024-12-18
  FDA Approved: IDACIO — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for IDACIO (adalimumab-aacf) from Fresenius Kabi USA, LLC.

• FDA approval · 2024-12-17
  FDA Approved: LEFLUNOMIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Leflunomide from Lupin Pharmaceuticals, Inc., indicating FDA approval of changes to this gen…

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• FDA approval · 2024-12-17
  FDA Approved: STEQEYMA — Original Application (CELLTRION USA, Inc.)

  FDA approved STEQEYMA (ustekinumab-stba) from Celltrion USA as a biosimilar to ustekinumab under an original biologics license application. …

• FDA approval · 2024-11-29
  FDA Approved: YESINTEK — Original Application (Biocon Biologics Inc.)

  FDA approved Yesintek (ustekinumab) from Biocon Biologics Inc. under an Original Application. It covers the established ustekinumab indicati…

• EMA approval · 2024-10-24
  EMA Authorised: Jylamvo (methotrexate) — Oresund Pharma ApS

  The European Medicines Agency authorised Jylamvo, a methotrexate product from Oresund Pharma ApS, for indications including psoriatic arthri…

• FDA approval · 2024-10-23
  FDA Approved: JYLAMVO — Supplemental Application (SHORLA ONCOLOGY INC.)

  The FDA approved a supplemental application for JYLAMVO (methotrexate) filed by SHORLA ONCOLOGY INC.

• FDA approval · 2024-10-10
  FDA Approved: IMULDOSA — Original Application (Accord BioPharma Inc.)

  The FDA approves Imuldosa (ustekinumab-srlf) from Accord BioPharma Inc. under an Original Biologics License Application, expanding treatment…

• FDA approval · 2024-09-27
  FDA Approved: OTULFI — Original Application (Fresenius Kabi USA, LLC)

  FDA approved OTULFI (ustekinumab-aauz) from Fresenius Kabi USA, LLC, as an original application. OTULFI is a monoclonal antibody targeting I…

• FDA approval · 2024-09-26
  FDA Approved: LEFLUNOMIDE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Leflunomide submitted by Zydus Lifesciences Limited.

• FDA approval · 2024-09-11
  FDA Approved: TREMFYA — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for TREMFYA (guselkumab) submitted by Janssen Biotech, Inc., affecting the drug's approved labeling …

• FDA approval · 2024-08-26
  FDA Approved: ADALIMUMAB-RYVK — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for ADALIMUMAB-RYVK, a biosimilar to adalimumab, submitted by Quallent Pharmaceuticals Health LL…

• FDA approval · 2024-06-28
  FDA Approved: USTEKINUMAB-TTWE — Original Application (Quallent Pharmaceuticals Health LLC)

  FDA approves a new biologic product, ustekinumab-tTWE, from Quallent Pharmaceuticals Health LLC, via an Original Biologics License Applicati…

• FDA approval · 2024-06-03
  FDA Approved: METHOTREXATE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' original application for methotrexate, authorizing the generic version of the drug.

• FDA approval · 2024-05-14
  FDA Approved: XELJANZ — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XELJANZ (tofacitinib) from Pfizer, granting an additional regulatory action under NDA 213082.

• FDA approval · 2024-05-14
  FDA Approved: XELJANZ XR — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approves a supplemental application for XELJANZ XR (tofacitinib) from Pfizer, introducing the extended-release formulation. Submission s…

• FDA approval · 2024-04-30
  FDA Approved: ABRILADA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for ABRILADA (adalimumab-afzb) from Pfizer Laboratories Div Pfizer Inc, authorizing its use as a…

• FDA approval · 2024-04-26
  FDA Approved: RINVOQ — Original Application (AbbVie Inc.)

  The FDA approved Rinvoq (upadacitinib) from AbbVie under an Original Application NDA, granting the drug its initial US marketing authorizati…

• FDA approval · 2024-04-25
  FDA Approved: OTEZLA — Supplemental Application (Amgen, Inc)

  The FDA approved Amgen's supplemental application for OTEZLA (apremilast), resulting in an approved supplemental change to the product label…

• FDA approval · 2024-04-16
  FDA Approved: SELARSDI — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved SELARSDI (USTEKINUMAB-AEKN) from Teva Pharmaceuticals USA, Inc. under an original Biologics License Application (BLA 761343).

• FDA approval · 2024-03-18
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for ustekinumab submitted by Janssen Biotech, Inc.

• FDA approval · 2024-02-22
  FDA Approved: ZYMFENTRA — Supplemental Application (CELLTRION USA Inc.)

  The FDA approved a supplemental application for ZYMFENTRA (infliximab-dyyb) submitted by Celltrion USA Inc.

• FDA approval · 2023-12-26
  FDA Approved: RENFLEXIS — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Renflexis (infliximab) submitted by Organon LLC.