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The selective oral Janus kinase 1 (JAK1) inhibitor ivarmacitinib helps improve the signs and symptoms of moderate-to-severe atopic dermatitis (AD) in adolescent and adult patients, while having a manageable safety profile, according to a phase III trial.
A recent phase III trial of NUC-1031/cisplatin has been terminated early due to ineffectiveness as first-line treatment for advanced biliary tract cancer (BTC).
Individuals with tardive dyskinesia (TD) report favourable outcomes with the VMAT2 inhibitor deutetrabenazine in an age subgroup analysis.
In the treatment of patients with relapsing polymyalgia rheumatica who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper, the use of sarilumab appears to produce clinically important improvements in health-related quality of life and patient-reported outcomes, according to the results of a phase III study.
In patients with invasive fungal disease (IFD) who have few or no treatment options, olorofim demonstrates efficacy and good tolerability, according to the results of a single-arm, open-label phase IIb study.
Patients with cancer who have received COVID-19 booster vaccinations are better protected against severe disease, according to real-world data from four healthcare systems in the US.
Treatment with apremilast results in fat mass reduction among patients with psoriatic arthritis (PsA), indicating positive cardiovascular (CV) and metabolic effects, which may lower the risk of CV events, a recent study has shown.
Significant delays occur in the initiation of tocilizumab (TCZ) therapy among patients with giant cell arteritis (GCA), reports a US study.
New drug applications approved by US FDA as of 1-15 June 2025 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.
Updated results from the phase IIIB HARMONIE trial demonstrate sustained efficacy of the long-acting monoclonal antibody nirsevimab against respiratory syncytial virus-associated lower respiratory tract infection (RSV-LRTI) hospitalization through day 181 post-dose.
