Showing 1031-1040 of 1539 results for "".
- Melanoma Rates Among Non-Hispanic American Indian/Alaska Natives Vary by Age, Region: Studyhttps://practicaldermatology.com/news/melanoma-rates-among-non-hispanic-american-indianalaska-native-individuals/2462199/A new study in JAMA Dermatology shed light on trends and incidence rates of invasive cutaneous melanoma in non-Hispanic American Indian/Alaska Native individuals. The cross-sectional observational study, focusing on a period from 1999 to 2019, included data drawn from a populati
- Can-Fite Receives Positive Response from FDA for Psoriasis Pediatric Planhttps://practicaldermatology.com/news/can-fite-receives-positive-response-from-fda-for-psoriasis-pediatric-plan/2462187/The U.S. Food and Drug Administration (FDA) gave a positive response to a study plan for piclidenoson in children suffering from psoriasis. The plan allows for children to enroll in the phase 3 pivotal clinical study aiming at registering the drug with both the FDA as well as the Europe
- FDA Approves Arcutis’ ZORYVE® (roflumilast) Topical Foam, 0.3% for the Treatment of Seborrheic Dermatitis in Patients 9 Years and Olderhttps://practicaldermatology.com/news/fda-approves-arcutis-zoryve-roflumilast-topical-foam-03-for-the-treatment-of-seborrheic-dermatitis-in-patients-9-years-and-older/2462186/Arcutis Biotherapeutics, Inc. announced the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for ZORYVE (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in those 9 years of age and older. ZORYVE foam provides rapid disease clearance and
- FDA Approves Adbry (tralokinumab-ldrm) for Treatment of Moderate-to-Severe AD in Pediatric Patients Aged 12-17 Yearshttps://practicaldermatology.com/news/fda-approval-of-tralokinumab-ldrm-for-the-treatment-of-moderate-to-severe-atopic-dermatitis-in-pediatric-patients-aged-12-17-years/2462185/The US Food and Drug Administration (FDA) has expanded the approval of Adbry® (tralokinumab-ldrm) to include pediatric patients aged 12 to 17 years with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies
- Kymera Update: First Patient Dosed in Phase 2 AD Clinical Trial of KT-474, a First-in-Class Investigational IRAK4 Degraderhttps://practicaldermatology.com/news/kymera-update-first-patient-dosed-in-phase-2-ad-clinical-trial-of-kt-474-a-first-in-class-investigational-irak4-degrader/2462177/The first patient has been dosed in the Phase 2 clinical trial (ADVANTA) evaluating KT-474 in AD, generating a $15 million milestone payment under its collaboration with Sanofi. KT-474 is an oral IRAK4 degrader, in development for the treatment of IL-1R/TLR-driven complex inflamma
- Journey’s Rosacea Therapy Clears Pre-NDA Hurdlehttps://practicaldermatology.com/news/journeys-rosacea-therapy-clears-pre-nda-hurdle/2462176/Journey Medical Corporation has successfully completed its pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) to treat rosacea. The company is on tr
- DermWire’s AD Pipeline Watch: TDM 180935 Performs Well in Phase 1 Studyhttps://practicaldermatology.com/news/dermwires-ad-pipeline-watch-tdm-180935-performs-well-in-phase-1-study/2462168/Technoderma Medicines, Inc. has completed a Phase 1 clinical trial of TDM-180935 topical ointment for Atopic Dermatitis (AD). TDM 180935 is a small molecule drug candidate that functions as a potent JAK1/Tyk2 small molecule inhibitor. Preclinical assessment of TDM-180935 has demon
- FDA Accepts Arcutis’ sNDA for Roflumilast Cream 0.15% for Treatment of AD in Adults and Children Down to Age 6https://practicaldermatology.com/news/fda-accepts-arcutis-snda-for-roflumilast-cream-015-for-treatment-of-ad-in-adults-and-children-down-to-age-6/2462159/The U.S. Food and Drug Administration (FDA) has accepted Arcutis’ supplemental new drug application (sNDA) for roflumilast cream 0.15% for the treatment of atopic dermatitis (AD) in adults and children down to age 6. Roflumilast cream is a once-daily, steroid
- FDA Grants Priority Review for Abeona's Pz-cel BLAhttps://practicaldermatology.com/news/fda-grants-priority-review-for-abeonas-pz-cel-bla/2462154/The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Biologics License Application (BLA) of Abeona Therapeutics Inc.’s pz-cel (prademagene zamikeracel), an investigational autologous, COL7A1 gene-corrected epidermal sheets for the treatment of patient
- First Patients Enrolled in Phase 2 Proof of Concept Trial of MC2-25 VLS in Vulvar Lichen Sclerosushttps://practicaldermatology.com/news/first-patients-enrolled-in-phase-2-proof-of-concept-trial-of-mc2-25-vls-in-vulvar-lichen-sclerosus/2462151/The first patients have been enrolled in a Phase 2a proof of concept trial evaluating the safety and efficacy of MC2-25 VLS, a new drug candidate for the treatment of urea- associated skin diseases, including vulvar lichen sclerosus. MC2-25 VLS is a based on a di-peptide that