September 26th 2023
Abeona Therapeutics is seeking Priority Review and approval of the therapy for patients with recessive dystrophic epidermolysis bullosa.
September 12th 2023
The IL-17A inhibitor did not meet its phase 2b/3 clinical trial primary end point.
The submission follows the announcement of recent long-term data of the drug in patients ages 6 years and older.
August 1st 2023
Both companies are hoping to make a positive impact in the neoadjuvant setting of cutaneous squamous cell carcinoma.
July 27th 2023
V940-001 is the first phase 3 study of a planned comprehensive clinical development program initiated after the positive primary analysis of the phase 2b KEYNOTE-942/mRNA-4157-P201 trial.
FDA Grants Orphan Drug Designation to Alrizomadlin for Stage IIB-IV Melanoma
The FDA has granted an orphan drug designation to alrizomadlin as a potential therapeutic option for patients with stage IIB-IV melanoma.
FDA Approves Shingrix Vaccine for Immunocompromised Patients
The newest FDA indication allows for greater distribution to younger but equally vulnerable immunocompromised patients.
Twyneo Receives FDA Approval for Acne
Twyneo, a tretinoin and benzoyl peroxide cream, has been approved by the FDA for the treatment of acne vulgaris in patients 9 years and older.
BioFactura Announces Commencement of Ustekinumab Biosimilar Phase 1 Trial
BFI-751, Biofactura’s biosimilar drug to ustekinumab will be investigated for the first time on human patients.
Belapectin, Pembrolizumab Show Early Activity, Tolerability in Metastatic Melanoma
The combination of belapectin plus pembrolizumab has demonstrated early potential for disease control with acceptable tolerability in patients with metastatic melanoma.
Sol-Gel Announces New Data for SGT-510 for Psoriasis
Sol-Gel has announced pre-clinical data on SGT-510, its roflumilast drug, for the treatment of psoriasis.
Journey Medical, Dr. Reddy’s to Commercialize and Develop DFD-29 for Rosacea
Journey Medical Corporation and Dr. Reddy’s Laboratories Ltd. have joined forces for the development and commercialization of DFD-19 as a treatment for rosacea.
Brickell BioTech Provides Update on Phase 3 Sofpironium Bromide Gel Studies
Brickell BioTech, Inc announced the completion of its Cardigan I study and final enrollment of the Cardigan II study.
FDA Approves Pembrolizumab for Locally Advanced cSCC
The FDA has expanded the label for pembrolizumab for use as a monotherapy in the treatment of patients with locally advanced cutaneous squamous cell carcinoma that is not curable by surgery or radiation.
OncoSec, Merck Enter Agreement for Late-Stage Metastatic Melanoma Combo
OncoSec Medical Inc. and Merck have entered into a supply and clinical trial agreement for pembrolizumab (Keytruda) and tavokinogene telseplasmid (Tavo) for the potential treatment of late-stage metastatic melanoma.
Arcutis Biotherapeutics to Terminate Phase 2a Vitiligo Study
Arcutis Biotherapeutics announced early termination of its phase 2a trial evaluating ARQ-252 as a potential treatment for vitiligo citing to inadequate local drug delivery to the skin.
July FDA Approvals to Watch
Explore what dermatologic drugs the FDA will decide to approve during July 2021.
Cemiplimab Approved for BCC in Europe
The European Commission has approved cemiplimab for the treatment of locally advanced or metastatic basal cell carcinoma in adults.
FDA Fails to Provide Approval Decision on Upadacitinib for PsA
The FDA announces it did not meet the June 25 PDUFA action date on the sNDA for active psoriatic arthritis treatment, upadacitinib.
Guselkumab Demonstrates Efficacy in Phase 3b Study
COSMOS phase 3b study data demonstrated the effectiveness of guselkumab in patients diagnosed with psoriatic arthritis.
FDA Approves New Dose for Dupilumab Pre-filled Pen
The FDA has approved a single-dose pre-filled pen for dupilumab (Dupixent, Sanofi and Regeneron) for at-home administration.
StrataGraft Approved for Thermal Burns in Adults
Mallinckrodt announces the FDA approval of StrataGraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen – dsat) for the treatment of adults with thermal burns.
Molluscum Contagiosum Treatment Demonstrates Success in Phase 3 Trial
The B-SIMPLE4 phase 3 trial achieved positive efficacy results for the treatment of molluscum contagiosum.
Secukinumab Approved for Plaque Psoriasis in Children, Adolescents
John Browning, MD, FAAD, FAAP, MBA, discusses the impact of the recent FDA approval of secukinumab (Cosentyx, Novartis) for the treatment of moderate to severe plaque psoriasis in children and adolescents.
Upadacitinib for the Treatment of Atopic Dermatitis
Emma Guttman-Yassky, MD, sits down with Dermatology Times® to discuss recently published results of a phase 3 study evaluating upadacitinib (Rinvoq, AbbVie) as a potential treatment of atopic dermatitis.
FDA to Initiate Pre-Approval Inspection of DAXI Manufacturing Facility
Revance provides an update on the approval process for its injectable daxibotulinumtoxinA (DAXI) for the treatment of glabellar lines.
Tapinarof Cream Submitted for Approval for Treatment of Plaque Psoriasis
Dermavant has submitted a New Drug Application (NDA) to the FDA seeking approval for its novel topical for the treatment of mild, moderate, and severe plaque psoriasis in adult patients.
Cosibelimab Being Evaluated for Metastatic cSCC
The anti–PD-L1, fully human monoclonal antibody cosibelimab will be examined in a cohort of patients with metastatic cutaneous squamous cell carcinoma (cSCC) as part of an ongoing phase 1 study.
Ruxolitinib Safe, Effective for Vitiligo in Adolescents, Adults
Ruxolitinib cream (Jakafi, Incyte) demonstrated positive results in 2 phase 3 studies investigating the topical for treatment of vitiligo in patients 12 years and older
Off-label Biologics Target Wide Range of Skin Diseases
Novel biologics are moving into off-label indications to expand the dermatologic armamentarium for a broad range of inflammatory skin diseases.
FDA Grants Orphan Drug Status to ITIL-168 for Melanoma
The FDA has granted an Orphan Drug designation to the investigational tumor-infiltrating lymphocyte therapy ITIL-168 for the treatment of patients with stage IIB to IV melanoma.
Voltaire-X Phase 3 Data for Chronic Plaque Psoriasis Support Interchangeability Application
Voltaire-X study data shows that switching several times between Cyltezo and Humira results in similar pharmacokinetics, efficacy, immunogenicity, and safety in people with moderate to severe chronic plaque psoriasis.
Otezla Phase 3 ADVANCE Trial Reports Improvement in Plaque Psoriasis Severity
Phase 3 trial of Otezla shows improved measures of disease severity in adults with mild to moderate plaque psoriasis regardless of their Body Surface Area affected by the disease.
Nemolizumab Demonstrates Significant Improvement of AD Symptoms in Phase 2b Trial
Nemolizumab shows positive results according to a recently published post hoc analysis of a phase 2b trial evaluating the drug vs placebo in adult patients with moderate to severe atopic dermatitis (AD).
Pembrolizumab Demonstrates Robust Activity in Advanced and Recurrent/Metastatic CSCC
Single-agent pembrolizumab yielded robust antitumor activity in patients with locally advanced or recurrent/metastatic cutaneous squamous cell carcinoma.
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