Reviewing the Top Dermatology Headlines of 2023

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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.

FDA Grants Priority Review of Abeona’s Pz-cel BLA for Recessive DEB

The FDA’s PDUFA target date is May 25, 2024.

A Shift in Adjuvant Therapy: FDA Approves Nivolumab for Completely Resected Stage IIB/C Melanoma

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

FDA Grants Breakthrough Therapy Designation to QTORIN Rapamycin for Microcystic Lymphatic Malformations

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

Proposed FDA Ban of Formaldehyde in Hair Relaxers: What Comes Next?

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

FDA Approves Ustekinumab-auub as Interchangeable Biosimilar to Stelara for Plaque Psoriasis, Psoriatic Arthritis, and More

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

FDA Approves Secukinumab for Hidradenitis Suppurativa

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

IDP-126 Approved by FDA for Treatment of Acne

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

FDA Issues Complete Response Letter for Dupilumab sBLA for Chronic Spontaneous Urticaria

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

FDA Approves Bimekizumab for Moderate to Severe Plaque Psoriasis

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

FDA Clears IND for KYV-101 for the Treatment of Scleroderma

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

FDA Approves Roflumilast Cream 0.3% In Children 6 to 11 Years With PsO

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

FDA Issues Complete Response Letter for Lebrikizumab

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

Abeona Submits Biologics License Application to FDA for EB-101

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

FDA Clears Sofwave SUPERB Applicator for the Treatment of Acne Scars

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

Breakthrough Therapy Designation Granted to SD-101 for Treatment of Epidermolysis Bullosa

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

B-VEC Approved for the Treatment of Dystrophic Epidermolysis Bullosa

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

FDA Approves Ritlecitinib For Severe Alopecia Areata

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

FDA Clears Brella SweatControl Patch for Reduced Primary Axillary Hyperhidrosis

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

Abrocitinib Approved for Adolescents With Atopic Dermatitis

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

FDA Clears PicoWay Laser for Melasma, Lentigines, and More

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

VP-102 Now Approved for the Treatment of Molluscum Contagiosum

Verrica’s VP-102 is the first FDA-approved treatment for molluscum lesions.

KT-474 Demonstrates Efficacy and Promise in Atopic Dermatitis and Hidradenitis Suppurativa Study

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

European Commission Approves Lebrikizumab for Atopic Dermatitis

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

LEO Pharma to Acquire Timber Pharmaceuticals

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

Artificial Intelligence: Friend or Foe?

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.