Drug Watch

The FDA has assigned a Prescription Drug User Fee Act target action date for August 13.

The anticipated PDUFA date is November 4, 2024.

Shawn Kwatra, MD, shares positive updates on phase 2 oral povorcitinib for prurigo nodularis at AAD 2024.

New data was presented at the American Academy of Dermatology Annual Meeting in San Diego, California.

Alphyn’s first-in-class therapeutic is designed to treat the immune system component, and more specifically the bacterial component, of AD.

Miller, Vice President, Immunodermatology Disease Area Leader, Johnson & Johnson, spoke with Dermatology Times about recently published data supporting JNJ-2113's potential in this indication.

Lifileucel is a tumor-derived autologous T cell immunotherapy.

The FDA has also granted nemolizumab Priority Review for prurigo nodularis.

Tapinarof cream demonstrated highly statistically significant improvement in the primary end point of vIGA-AD treatment success over vehicle at week 8.

Data from the FRONTIER 1 clinical trial were recently published in the New England Journal of Medicine.

Marcelo Bigal, MD, PhD, discusses VENT-03's potential as a small molecule therapeutic in dermatology, among other fields.

The VISIBLE clinical program will create a longitudinal collection of more than 20,000 clinical images across all skin tones.

The high-concentration and citrate-free biosimilar was first available in a single 40 mg dose.

Higher response rates were observed in patients treated with lutikizumab. The drug will now advance to phase 3 clinical trials.

The approval marks a milestone for patients ages 1 year of age and older who face the persistent, highly contagious condition.

The filing is supported by positive phase 3 clinical trial data.

Soligenix shared today positive top-line data stemming from the phase 2a clinical trial.

The BLA submission for DMB-3115 is rooted in phase III multi-regional clinical trials focusing on plaque psoriasis patients. The results demonstrated a high similarity between DMB-3115 and ustekinumab in terms of quality, safety, and efficacy.

Dermatology Times is reviewing some of the most anticipated PDUFA dates of the upcoming year.

Catch up on coverage of FDA-approved drugs in 2023.

Chiesi Global Rare Diseases recently announced the approval of the topical treatment.

Here is a recap of the drugs and treatments approved to keep in mind for the new year.

Roflumilast foam 0.3% is the first FDA-approved drug for seborrheic dermatitis with a new mechanism of action in over 2 decades. Christopher Bunick, MD, PhD; Shawn Kwatra, MD; and Peter Lio, MD, share expert insights.

The confirmatory phase 3 trial demonstrated significant efficacy of TO-208 versus a placebo.

Adbry (tralokinumab-LDRM) is now the first and only FDA-approved biologic for AD binding to and inhibiting IL-13.

Biolojic’s BD9 is a dual specific antibody that can block both Thymic stromal lymphopoietin and IL-13.

The study evaluated the efficacy of AIV001 in superficial, nodular, and mixed BCC tumors.

One of the specific areas of focus will be non-melanoma skin cancer.

In January 2023, adalimumab-atto became the first biosimilar product available for the reference product adalimumab.

KT-474 is a first-in-class, investigational IRAK4 degrader.