As 2025 drew to a close, The Dermatology Digest editors and staff weighed in on some of the biggest drug and device approvals of the year and how they will shape, and in some cases revolutionize, patient care.
Among the biggest headline-grabbing news stories of 2025 at press time were a new drug for chronic hand eczema (CHE), a nod for an old favorite in bullous pemphigoid, and the first-ever Bruton’s tyrosine kinase (BTK) inhibitor approved for chronic spontaneous urticaria (CSU).
“It is a really exciting time to be a dermatologist! Our more detailed understanding of disease pathogenesis has opened the door to development of a multitude of new agents with novel mechanisms of action,” says Ted Rosen, MD, Professor of Dermatology at Baylor College of Medicine in Houston, TX and Editor-in-Chief of The Dermatology DigestÒ.” It is always advantageous to have an expended set of therapeutic options for many of our heretofore difficult-to-treat disorders.”
February 2025
Mirdametinib (Gomekli, SpringWorks Therapeutics) for the treatment of patients with neurofibromatosis type 1-associated plexiform neurofibromas.
March 2025
Omalizumab-igec (Omlyclo, Celltrion) injection as the first biosimilar to be designated as interchangeable with Xolair (Genentech) for asthma, chronic rhinosinusitis with masal polyps, food allergies, and urticaria.
May 2025
Roflumilast foam 0.3% (Zoryve, Arcutis) for plaque psoriasis in adults and adolescents aged 12 and up.
The next generation of Sun Pharma’s BLU-U Blue Light Photodynamic Therapy (PDT) Illuminator for treating actinic keratoses (AK). The new LED BLU-U features light-emitting diode (LED) panels as a replacement for the previous model’s fluorescent tubes. The new model (LED BLU-U), in combination with Levulan Kerastick (aminolevulinic acid HCl) Topical Solution, 20%, is indicated for the treatment of minimally to moderately thick AK of the face, scalp, or upper extremities.
Ustekinumab-hmny (Starjemza, Bio-Thera Solutions, and Hikma Pharmaceuticals) injection, a Stelara biosimilar, for plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
June 2025
Dupilumab (Dupixent, Sanofi & Regeneron) for the treatment of adults with bullous pemphigoid (BP). Dupilumab is the first and only targeted medicine to treat BP in the US.
A second Netherton Syndrome (NS) pivotal clinical study from Quoin Pharmaceuticals Ltd is greenlighted for QRX003, a topical lotion formulated with a broad-spectrum serine protease inhibitor that has been shown to significantly downregulate the hyperactivity of the kallikreins in the skin responsible for the excessive skin shedding associated with NS.
A new presentation of Celltrion, Inc’s Stelara (ustekinumab) biosimilar. Steqeyma is now available in a 45mg/0.5mL solution in a single-dose vial for subcutaneous injection. The additional presentation is approved for the treatment of pediatric patients aged 6 to 17 years, weighing less than 60kg, with plaque psoriasis or psoriatic arthritis.
July 2025
Pelthos Therapeutics officially launches berdazimer topical gel, 10.3% (Zelsuvmi) for the treatment of molluscum contagiosum in adults and pediatric patients one year of age and older.
Fast Track designation for Nektar Therapeutics’ rezpegaldesleukin for the treatment of severe-to-very-severe alopecia areata (AA) in adults and pediatric patients aged 12 and older who weigh at least 40 kilograms. Rezpegaldesleukin is an investigational biologic therapy that targets the interleukin (IL)-2 receptor complex in the body to stimulate the proliferation of inhibitory immune cells known as regulatory T cells (Tregs).
Delgocitinib cream (Anzupgo, LEO Pharma) for the topical treatment of moderate-to-severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable.
Delgocitinib cream inhibits the janus kinase/signal transducer and activator of the transcription (JAK-STAT) pathway, specifically blocking the activity of JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2), and suppresses the various inflammatory responses that play a key role in the onset and subsequent flares of CHE.
Leqselvi (deuruxolitinib) becomes available for prescription in the United States for adults with severe alopecia areata following a patent dispute resolution.
August 2025
Cynosure Lutronic’s XERF system, a radiofrequency (RF) technology, cleared for skin tightening.
September 2025
Obagi saypha MagIQ injectable hyaluronic acid (HA) gel, the first intradermal filler product in the Obagi saypha collection for commercial use in the US market.
Ruxolitinib cream 1.5% (Opzelura, Incyte) for the short-term and non-continuous chronic treatment of mild-to-moderate atopic dermatitis (AD) in non-immunocompromised children aged 2 and older whose disease is not well-controlled with topical prescription therapies, or when those therapies are not recommended.
Label update for beremagene geperpavec-svdt (Vyjuvek, Krystal Biotech, Inc.) that expands the eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients from birth and provides patients full flexibility with respect to applying and managing wound dressings.
510(k) clearance for Dermalogica’s PRO Pen Microneedling System as a Class II medical device.
Icotrokinra, an investigational oral interleukin (IL)-23 blocker, bested deucravacitinib (Sotyktu, BMS) in efficacy and safety, according to the first reported head-to-head trials.The Phase 3 data were presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress in Paris, France.
October 2025
Expanded indications for adalimumab-aaty (Humira) biosimilar Yuflyma (Celltrion) and its unbranded version, including the treatment of hidradenitis suppurativa (HS) in adolescents aged 12 and older, and uveitis (UV) in pediatric patients aged 2 and up.
Roflumilast cream 0.05% (Zoryve, Arcutis) for the topical treatment of mild-to-moderate atopic dermatitis (AD) in children aged 2 to 5.
Remibrutinib (Rhapsido, Novartis) as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. It is the first FDA-approved Bruton’s tyrosine kinase inhibitor (BTKi) for CSU.
Cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (cSCC) at high risk of recurrence after surgery and radiation.
Guselkumab (Tremfya) for the treatment of children six years and up who also weigh at least 40 kg with moderate-to-severe plaque psoriasis, who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis (PsA).
The Dermatology Digest (TDD)® and The Journal of Dermatology for Nurse Practitioners and Physician Assistants (JDNPPA)® win three accolades at the 2025 Folio Eddie & Ozzie Awards for outstanding editorial content, design, and storytelling in medical publishing and B2B media.
The FDA accepts the resubmission of Replimune Group, Inc.’s Biologics License Application (BLA) for RP1 in combination with nivolumab (Opdivo, Bristol Myers Squibb) for the treatment of advanced melanoma in patients who progress on an anti-PD-1-containing regimen. The PDUFA date set by the FDA is April 10, 2026, based on a Class II resubmission timeline.
November 2025
Castle Biosciences, Inc. launches AdvanceAD-Tx, a gene expression profile (GEP) test designed to guide systemic treatment decision-making in patients ages 12 and up with moderate-to-severe AD.
Galderma’s Restylane Lyft with Lidocaine for augmentation of the chin region in patients aged 21 and up with mild-to-moderate chin retrusion.
Merz Aesthetics’ Ultherapy PRIME for improving the appearance of skin laxity on the anterior and posterior arms, as well as the abdomen.
The U.S. FDA accepts a supplemental New Drug Application (sNDA) for roflumilast cream 0.3% (Zoryve, Arcutis) to treat plaque psoriasis in children aged 2 to 5. The PDUFA target action date is June 29, 2026.
The U.S. FDA approved a label update for cosibelimab-ipdl (Unloxcyt, Sun Pharma) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced (la) CSCC who are not candidates for curative surgery or curative radiation. The updated label now incorporates long-term follow-up data from the CK-301-101 trial, a multicenter, multicohort, open-label study of 109 patients (31 with laCSCC; 78 with mCSCC), which showed patients receiving cosibelimab-ipdl experienced durable clinical responses. With this updated label, Sun Pharma intends to commercially launch cosibelimab-ipdl in early 2026
