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Anti–IL-23 monoclonal antibody shows promise in plaque psoriasis

22 Dec 2024

QX004N, a humanized IgG1λ monoclonal antibody targeting IL-23, is superior to placebo in the treatment of patients with moderate to severe plaque psoriasis, according to a phase I trial.

Anti–IL-23 monoclonal antibody shows promise in plaque psoriasis

22 Dec 2024

Original New Drug Application Approvals by US FDA (1-15 December 2024)

20 Dec 2024

New drug applications approved by US FDA as of 1-15 December 2024 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.

Original New Drug Application Approvals by US FDA (1-15 December 2024)

20 Dec 2024

Nemolizumab works well for prurigo nodularis

19 Dec 2024

Targeting interleukin-31 signalling with nemolizumab appears to produce substantial improvements in core signs and symptoms of prurigo nodularis (PN), as shown in the phase III OLYMPIA 1 trial.

Nemolizumab works well for prurigo nodularis

19 Dec 2024

Original New Drug Application Approvals by US FDA (16-30 November 2024)

06 Dec 2024

New drug applications approved by US FDA as of 16-30 November 2024 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.

Original New Drug Application Approvals by US FDA (16-30 November 2024)

06 Dec 2024

Low-dose IL-2 therapy safe, effective in moderate-to-severe bullous pemphigoid

03 Dec 2024

Low-dose interleukin 2 (IL-2) therapy may be used to treat moderate-to-severe bullous pemphigoid (BP), as shown by earlier treatment responses of patients in a recent study.

Low-dose IL-2 therapy safe, effective in moderate-to-severe bullous pemphigoid

03 Dec 2024

MVA-BN vax shows favourable safety, tolerability in adolescents in phase II study

18 Nov 2024 by

Interim data from a phase II trial demonstrate the safety and tolerability of the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine in adolescents. MVA-BN is a live attenuated, non-replicating orthopoxvirus vaccine licensed in the US for smallpox and mpox prevention.

MVA-BN vax shows favourable safety, tolerability in adolescents in phase II study

18 Nov 2024

Abrocitinib provides early and sustained efficacy in atopic dermatitis

18 Nov 2024

Abrocitinib provides early relief of itch and skin pain as well as sustained efficacy for >2 years in patients with moderate-to-severe atopic dermatitis (AD), post-hoc analyses of JADE trials have shown. Notably, long-term efficacy was observed irrespective of prior exposure to systemic therapies.

Abrocitinib provides early and sustained efficacy in atopic dermatitis

18 Nov 2024

Original New Drug Application Approvals by US FDA (1-15 November 2024)

18 Nov 2024

New drug applications approved by US FDA as of 1-15 November 2024 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.