December 2nd 2024
If granted, guselkumab will be approved to treat children ages 6 and younger with severe plaque psoriasis and children ages 5 and younger with juvenile psoriatic arthritis.
November 25th 2024
According to the company, comparative tests revealed PN-881 surpasses or matches the efficacy of current injectable IL-17 therapies.
November 20th 2024
The drug is the first FDA-approved treatment for moderate to severe HS that selectively inhibits both IL-17A and IL-17F.
November 14th 2024
Delgocitinib is indicated for adults with CHE who either do not respond to or cannot use topical corticosteroids.
November 12th 2024
Abeona's pz-cel has been granted a April 29, 2025, PDUFA date.
New Positive Results of Oral IL-23 Receptor Antagonist for Psoriasis
JNJ-2113 met primary endpoints in the FRONTIER 1 clinical trial.
Verrica Pharmaceuticals' Resubmitted NDA for VP-102 Accepted by FDA
VP-102 could be the first FDA-approved treatment for molluscum contagiosum.
FDA Accepts Bristol Myers Squibb’s sBLA for Nivolumab for Resected Stage IIB/C Melanoma
Nivolumab for completely resected stage IIB or IIC melanoma is also validated by the European Medicines Agency.
Bruce Feinberg, DO, Discusses 2023 Biosimilars Report From Cardinal Health
Biosimilars have been a trending topic in 2023 with 8 adalimumab biosimilars expected to hit the market this year.
Arcutis Submits NDA for Roflumilast Foam for the Treatment of Seborrheic Dermatitis
Adolescents and adults with seborrheic dermatitis may have a new topical treatment soon.
Abrocitinib Approved for Adolescents With Atopic Dermatitis
The expanded approval is based on data from a recent phase 3 clinical trial.
New Positive Phase 3 Data of Delgocitinib for Chronic Hand Eczema
Chronic hand eczema can have a significant negative impact on quality of life.
HS Treatment Response Rates Continue to Improve with Secukinumab at Week 52
Newly released safety and efficacy data on Novartis’ secukinumab for hidradenitis suppurativa is published in The Lancet.
First Adalimumab Biosimilar, Adalimumab-atto, Available in the US
Christopher Bunick, MD, PhD, and Raj Chovatiya, MD, PhD, discuss the benefits of adalimumab-atto and the future of additional biosimilars in 2023.
Spesolimab Shows Significant Prevention of GPP Flares up to 48 Weeks
Preventing generalized pustular psoriasis may be possible based on recent data.
Dermatology Drug Pipeline 2023
Breakthroughs and approvals we can expect in the coming year.
Novan Submits NDA for Berdazimer Gel for the Treatment of Molluscum Contagiosum
Potential FDA approval is expected in the first quarter of 2024.
SNDA Submitted for Roflumilast Cream for the Treatment of Plaque Psoriasis Down to 2 Years
Arcutis Biotherapeutics' indication expansion is based on data from MUSE studies.
Positive New Results of Tapinarof Cream Study for Pediatric Patients with AD
Dermavant announced positive results from its pediatric maximal usage study.
Eli Lilly Submits BLA for Lebrikizumab AD Treatment
BLA submission is based on phase 3 trial results evaluating the safety and efficacy of lebrikizumab.
FDA Accepts Phase 1 Clinical Trials of Exosome Therapy for AD
Brexogen Inc.’s exosome therapy is the first entry of a clinical trial of exosome treatment for atopic dermatitis.
Phase 2a Clinical Trial Enrollment for AD Passes Halfway Point
Alphyn Biologics’ study of AB-101a also evaluates patients who suffer from bacterial infections associated with atopic dermatitis.
New Study Data of Roflumilast Foam for Scalp and Body Psoriasis
Arcutis Biotherapeutics announced positive results from the ARRECTOR phase 3 trial.
FDA Approves Spesolimab-Sbzo Injection for GPP Flares
Boehringer Ingelheim’s first treatment option for adults will help manage burdensome flares.
Arcutis Finalizes Enrollment in Pivotal Phase 3 Trial of Roflumilast Cream for AD
INTEGUMENT-1 and 2 trial data for atopic dermatitis are expected at the end of 2022.
FDA Accepts BLA for NexoBrid to Treat Severe Burns
MediWound’s new burn care therapy alleviates risks associated with surgical debridement.
JUVÉDERM VOLUX XC approved by FDA for jawline definition
Allergan Aesthetics announced the US Food and Drug Administration has approved the hyaluronic acid filler for jawline definition improvement.
FDA Approves Roflumilast Cream 0.3% for Plaque Psoriasis
Arcutis Biotherapeutics’ roflumilast cream will provide relief to patients aged 12 years or older diagnosed with plaque psoriasis.
Alopecia Areata Gets FDA-Approved Drug
Approval of a novel oral JAK inhibitor specifically indicated for this challenging condition fills a long unmet need.
NIH Launches mRNA Nipah Vaccine Clinical Trial
An early-stage clinical trial will evaluate an investigational vaccine to prevent Nipah virus infection.
FDA Approves Noblepharma’s Sirolimus Topical Gel 0.2%
The groundbreaking approval of sirolimus topical gel brings relief to patients with facial angiofibroma related to tuberous sclerosis complex with the first FDA-approved topical treatment.
How Dupixent Improves Moderate-to-Severe AD in Adult and Pediatric Patients
Cynthia J. Trickett, PA-C, MPAS, discusses the personal and clinical effects of atopic dermatitis in adult and pediatric patients at the Maui Derm NP+PA 2022 Summer Conference in Colorado Springs, Colorado.
FDA Issues Third CRL in 2 years to Verrica Pharmaceuticals
Verrica is complying with the FDA through 3 Complete Response Letters to achieve the first FDA-approved treatment of molluscum contagiosum.
Managing Complex Diseases with Therapeutic Monitoring Program
Complex diseases can be difficult to manage for optimal outcomes. Monitoring programs of therapies can help with that management
Pointers With Portela: New FDA Treatment for Alopecia Areata
In this week’s Pointers with Dr Portela, the 208SkinDoc talks the newest approval of baricitinib (Olumiant; Eli Lilly and Company) for the treatment of alopecia areata.