FDA Accepts sNDA for Arcutis' Roflumilast Cream 0.15% for Atopic Dermatitis, Sets July 2024 PDUFA Date

The sNDA is supported by positive data from the phase 3 INTEGUMENT-1 and INTEGUMENT-2 trials.

The FDAs PDUFA target date is May 25, 2024.

Immunotherapies, including PD-1 checkpoint inhibitors such as nivolumab, have improved the treatment options for patients with advanced melanoma.

There are currently no FDA-approved therapies for the rare, genetic disease.

Christopher Bunick, MD, PhD, and David Light, CEO of Valisure, weigh in on the proposed formaldehyde ban.

The approved indication makes Wezlana the first approved interchangeable biosimilar to Stelara.

Secukinumab is currently the only IL-17A inhibitor approved for the condition.

The US Food and Drug Administration has approved IDP-126 gel for patients with acne.

The CRL states that additional efficacy data is needed in order to support approval.

Bimekizumab is now the first and only approved IL-17A and IL-17F inhibitor for this indication.

Kyverna Therapeutics can now initiate its phase 1/2 open-label, multicenter study of KYV-101.

The approval provides pediatric patients with a steroid-free topical therapy.

No concerns were cited about the clinical data package, safety, or label of lebrikizumab.

Abeona Therapeutics is seeking Priority Review and approval of the therapy for patients with recessive dystrophic epidermolysis bullosa.

From its clinical study, 97% of patients saw improvement in acne scars after 3 treatment sessions.

The topical cream is the first epidermolysis bullosa treatment to receive Breakthrough Therapy designation from the FDA.

Beremagene geperpavec is the first FDA-approved treatment for DEB, a rare and burdensome disease.

Ritlecitinib is the first and only treatment cleared for adolescents with severe alopecia areata.

Patients can achieve reduced excessive underarm sweating after one in-office treatment.

The expanded approval is based on data from a recent phase 3 clinical trial.

The picosecond system has previously been approved for treating acne scarring, pigmented lesions, tattoo removal, and wrinkles.

Verricas VP-102 is the first FDA-approved treatment for molluscum lesions.

Jared Gollob, MD, Chief Medical Officer of Kymera Therapeutics, spoke with Dermatology Times to discuss these trial results.

Germany will be the first country where lebrikizumab will be available for prescription, with a subsequent rollout across European countries throughout 2024.

Timber Pharmaceuticals has been developing TMB-001 for the treatment of congenital ichthyosis.

This month's cover feature delves into the new applications and use of AI in dermatology and considers how AI can support clinicians rather than hinder them.

See any important headlines we may have missed this year? Share with us by emailing our team at DTEditor@mmhgroup.com.

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Reviewing the Top Dermatology Headlines of 2023 - Dermatology Times