Plaque Psoriasis
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CLINICAL_TRIALS trial_result · 2024-01-18Clinical Trial Update: Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis [Phase 3]
Phase 3 trial comparing subcutaneous DMB-3115 to Stelara in moderate to severe chronic plaque psoriasis completed with results posted.
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CLINICAL_TRIALS trial_result · 2024-01-09Clinical Trial Update: Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab [Phase 4]
A Phase 4 trial comparing brodalumab with guselkumab in plaque psoriasis patients with inadequate response to ustekinumab was terminated, an…
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FDA approval · 2023-12-26FDA Approved: RENFLEXIS — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Renflexis (infliximab) submitted by Organon LLC.
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FDA approval · 2023-12-15FDA Approved: ZORYVE — Original Application (Arcutis Biotherapeutics, Inc.)
FDA approved ZORYVE (roflumilast) topical cream as an original application for treating plaque psoriasis.
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FDA approval · 2023-12-15FDA Approved: HULIO — Supplemental Application (Biocon Biologics Inc)
The FDA approved a supplemental application for HULIO, Biocon Biologics' biosimilar adalimumab (adalimumab-fkJP).
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CLINICAL_TRIALS trial_result · 2023-12-15Clinical Trial Update: A Study to Investigate ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis [Phase 3]
Phase 3 trial of ABP 654 for moderate to severe plaque psoriasis has completed and results have been posted.
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CLINICAL_TRIALS trial_result · 2023-12-15Clinical Trial Update: Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-215) [Phase 2]
Phase 2 trial assessing pharmacokinetics and safety of ARQ-151 in children with plaque psoriasis completed with results posted in 2023.
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CLINICAL_TRIALS trial_result · 2023-12-07Clinical Trial Update: Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis [Phase 3]
Phase 3 study evaluating efficacy and safety of apremilast in children aged 6 to 17 with moderate to severe plaque psoriasis is completed. R…
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FDA approval · 2023-11-30FDA 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…
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FDA approval · 2023-11-29FDA Approved: CLOBETASOL PROPIONATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approves Glenmark's supplemental application for clobetasol propionate, a potent topical corticosteroid, enabling an approved supplement…
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CLINICAL_TRIALS trial_result · 2023-11-29Clinical Trial Update: Study Evaluation of the Efficacy, Safety and Immunogenicity of Adalimumab in Comparison With Humira® [Phase 3]
Phase 3 trial evaluating the efficacy, safety, and immunogenicity of adalimumab compared with Humira in plaque psoriasis.
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FDA approval · 2023-11-21FDA 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…
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FDA approval · 2023-11-20FDA 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…
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FDA approval · 2023-11-03FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)
FDA approves a supplemental application for HUMIRA (adalimumab) to Cordavis Limited, enabling an additional manufacturing/supply pathway for…
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FDA approval · 2023-10-31FDA Approved: WEZLANA — Original Application (Nuvaila Limited)
FDA approved WEZLANA (ustekinumab-auub) from Nuvaila Limited under an original Biologics License Application.
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FDA approval · 2023-10-31FDA Approved: WEZLANA — Original Application (Nuvaila Limited)
This entry documents the original Biologics License Application for WEZLANA, a ustekinumab-AUUB monoclonal antibody developed by Nuvaila Lim…
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CLINICAL_TRIALS trial_result · 2023-10-27Clinical Trial Update: Combination of Halobetasol Propionate and Tazarotene Lotion (Duobrii®) for Palmoplantar Plaque Type Psoriasis [Phase 4]
Phase 4 trial update on the combination of halobetasol propionate and tazarotene lotion (Duobrii) for palmoplantar plaque-type psoriasis, wi…
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FDA approval · 2023-10-20FDA Approved: ZYMFENTRA — Original Application (CELLTRION USA Inc.)
FDA approved ZYMFENTRA (inflximab-dyyb) from Celltrion USA as a biosimilar to infliximab (Remicade), based on demonstration of biosimilarity…
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FDA approval · 2023-10-18FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)
The FDA approved a supplemental application for Enbrel (etanercept) submitted by Immunex Corporation.
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FDA approval · 2023-10-17FDA Approved: BIMZELX — Original Application (UCB, Inc.)
FDA approved BIMZELX (bimekizumab) from UCB, Inc. via an original biologics license application, marking the first approval of this monoclon…
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FDA approval · 2023-10-06FDA Approved: COSENTYX — Original Application (Novartis Pharmaceuticals Corporation)
FDA approved the original application for Cosentyx (secukinumab), a monoclonal antibody targeting IL-17A, for the treatment of plaque psoria…
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FDA approval · 2023-10-06FDA Approved: COSENTYX — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for Cosentyx (secukinumab) submitted by Novartis Pharmaceuticals Corporation.
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CLINICAL_TRIALS trial_result · 2023-09-28Clinical Trial Update: Study of NDI-034858 in Participants With Moderate to Severe Plaque Psoriasis [Phase 2]
Phase 2 trial of NDI-034858 in moderate to severe plaque psoriasis completed with posted results.
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FDA approval · 2023-09-21FDA Approved: ADALIMUMAB — Supplemental Application (CELLTRION USA, Inc.)
FDA approved a supplemental Biologics License Application for the adalimumab biosimilar ADALIMUMAB-AATY from Celltrion USA, approving its bi…
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FDA approval · 2023-08-23FDA Approved: DESOXIMETASONE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)
FDA approved a supplemental application for desoximetasone from Padagis Israel Pharmaceuticals Ltd, finalizing an update to the approved AND…