News
Yescarta Labeling Updated to Include Prophylactic Corticosteroid Use
The updated labeling is based on results from a safety management cohort from the ZUMA-1 study.
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News
Cibinqo Approved for Refractory, Moderate to Severe Atopic Dermatitis
The approval was based on data from the phase 3 JADE clinical trial program, which included the JADE MONO-1, JADE MONO-2, and JADE COMPARE trials.
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Rinvoq Gains FDA Approval for Atopic Dermatitis
The approval was based on data from three phase 3 trials that evaluated the efficacy and safety of upadacitinib in patients 12 years of age and older with moderate to severe atopic dermatitis who are candidates for systemic therapy.
Drugs in the Pipeline, News
FDA Grants Fast Track Designation to Orismilast for Atopic Dermatitis
The FDA's Fast Track process allows for expedited review of drugs that are expected to fill an unmet need.
News
Zolgensma Labeling Updated With Additional Safety Information
Zolgensma is an adeno-associated virus vector-based gene therapy.
News
Dupixent Asthma Indication Expanded to Include Younger Patients
The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 VOYAGE trial.
Drugs in the Pipeline, News
Rilzabrutinib Fails in Phase 3 Pemphigus Trial
Rilzabrutinib is an oral Bruton tyrosine kinase inhibitor currently in development for a number of immune-mediated diseases.
News
Non-Vitamin K Antagonist Oral Anticoagulants vs Warfarin in NVAF Patients
Findings may help with decision-making in this high-risk patient population.
News
Saphnelo Approved for Systemic Lupus Erythematosus
The Food and Drug Administration (FDA) has approved Saphnelo (anifrolumab-fnia) for the treatment of adults with moderate to severe systemic lupus erythematosus who are receiving standard therapy. Type I interferons (IFNs) play a role in the pathogenesis of systemic lupus erythematosus (SLE). Anifrolumab-fnia, a human immunoglobulin G1 kappa monoclonal antibody, binds to subunit 1 of…
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Tezepelumab Gets Priority Review for Severe Asthma
The BLA submission included data from the pivotal phase 3 NAVIGATOR trial that assessed tezepelumab in 1061 patients with severe, uncontrolled asthma.
