Psoriatic Arthritis

• CLINICAL_TRIALS trial_result · 2024-05-14
  Clinical Trial Update: The Diagnostic Ultrasound Enthesitis Tool (DUET) Study

  The DUET study, sponsored by Women's College Hospital, has completed its clinical evaluation of the Diagnostic Ultrasound Enthesitis Tool (D…

• CLINICAL_TRIALS research · 2024-05-10
  Clinical Trial Update: Tapering of Biologics in Inflammatory Arthritis Patients in Remission [NA]

  Clinical trial update from the University of Manchester on tapering biologic therapies in rheumatoid arthritis and psoriatic arthritis patie…

• 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…

• CLINICAL_TRIALS research · 2024-04-30
  Clinical Trial Update: Effectiveness of Digital Rehabilitation (SIMPLI.REHAB) in Hand Arthritis [NA]

  Clinical trial update on SIMPLI.REHAB digital rehabilitation for hand arthritis, currently not yet recruiting.

• 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…

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• CLINICAL_TRIALS trial_result · 2024-04-26
  Clinical Trial Update: Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis [Phase 3]

  A Phase 3 trial evaluating intravenous secukinumab demonstrated efficacy, safety, and tolerability in active psoriatic arthritis, with resul…

• CLINICAL_TRIALS research · 2024-04-26
  Clinical Trial Update: Korean College of Rheumatology Biologics and Targeted Therapy Registry

  A registry study in Korea tracking biologics and targeted therapies for rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthriti…

• 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.

• CLINICAL_TRIALS trial_result · 2024-02-09
  Clinical Trial Update: A Study to Investigate Efficacy, Tolerability and Safety of ABY-035 in Patients With Active Psoriatic Arthritis [Phase 2]

  Phase 2 clinical trial evaluating ABY-035 for efficacy, tolerability, and safety in active psoriatic arthritis has completed.

• CLINICAL_TRIALS trial_result · 2024-02-08
  Clinical Trial Update: Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis [Phase 3]

  Phase 3 trial update on tofacitinib in Chinese patients with active psoriatic arthritis reports efficacy and safety results.

• CLINICAL_TRIALS trial_result · 2024-01-05
  Clinical Trial Update: Efficacy, Safety, and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis. [Phase 4]

  This Phase 4 trial evaluated the efficacy, safety, and tolerability of apremilast for early oligoarticular psoriatic arthritis; the study ha…

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

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

• FDA approval · 2023-12-15
  FDA Approved: HULIO — Supplemental Application (Biocon Biologics Inc)

  The FDA approved a supplemental application for HULIO, Biocon Biologics' biosimilar adalimumab (adalimumab-fkJP).

• CLINICAL_TRIALS trial_result · 2023-12-13
  Clinical Trial Update: Bioequivalence Study of Two Products of Apremilast 30 mg Tablets in Healthy, Adult, Human Subjects [Phase 3]

  Phase 3 bioequivalence study of two Apremilast 30 mg tablet products completed in healthy adults.

• CLINICAL_TRIALS trial_result · 2023-12-01
  Clinical Trial Update: A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis [Phase 2]

  Phase 2 trial assessing long-term safety and efficacy of bimekizumab in psoriatic arthritis has completed with results posted.

• FDA approval · 2023-11-30
  FDA Approved: ADALIMUMAB — Supplemental Application (CELLTRION USA, Inc.)

  The FDA approved a supplemental Biologics License Application for the adalimumab biosimilar ADALIMUMAB-AATY from Celltrion USA, Inc., allowi…

• CLINICAL_TRIALS trial_result · 2023-11-30
  Clinical Trial Update: A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Active Psoriatic Arthritis [Phase 3]

  A Phase 3 clinical trial evaluated the safe and effective use of a prefilled safety syringe or auto-injector for subcutaneous self-injection…

• FDA approval · 2023-11-21
  FDA Approved: COSENTYX — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Cosentyx (secukinumab) submitted by Novartis Pharmaceuticals, incorporating changes to the a…

• FDA approval · 2023-11-20
  FDA Tentative Approval: TALTZ — Supplemental Application (Eli Lilly and Company)

  The FDA issued tentative approval for a supplemental application for TALTZ (ixekizumab) by Eli Lilly, indicating the submission is approvabl…

• FDA approval · 2023-11-08
  FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for CIMZIA (certolizumab pegol) from UCB, Inc., updating its labeling and/or indications.

• FDA approval · 2023-11-03
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approves a supplemental application for HUMIRA (adalimumab) to Cordavis Limited, enabling an additional manufacturing/supply pathway for…

• FDA approval · 2023-10-31
  FDA Approved: WEZLANA — Original Application (Nuvaila Limited)

  FDA approved WEZLANA (ustekinumab-auub) from Nuvaila Limited under an original Biologics License Application.