Showing 2901-2910 of 3415 results for "".
- 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
- FDA Accepts sBLA for Interchangeability Designation for Hadlima, a Humira Biosimilarhttps://practicaldermatology.com/news/fda-accepts-sbla-for-interchangeability-designation-for-hadlima-a-biosimilar-to-humira/2462131/The U.S. Food and Drug Administration (FDA) has accepted the Supplemental Biologics License Application (sBLA) for the interchangeability designation or Hadlima (adalimumab-bwwd) injection 40 mg/0.4 mL, a biosimilar to Humira(adalimumab). Once a biosimilar product is designated as an in
- Biosimilar News: FDA Approves Stelara Biosimilar Wezlanahttps://practicaldermatology.com/news/biosimilar-news-fda-approves-stelara-biosimilar-wezlana/2462118/The U.S. Food and Drug Administration (FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Stelara (ustekinumab) for psoriasis and multiple other inflammatory diseases. The FDA granted the approval of Wezlana to Amgen, Inc. Wezlana, like Stelar
- FDA Approves Cosentyx for HShttps://practicaldermatology.com/news/fda-approves-cosentyx-for-hs/2462109/The US Food and Drug Administration (FDA) has given its nod to Novartis’ Cosentyx (secukinumab) to treat moderate to severe hidradenitis suppurativa (HS) in adults. The IL-17A inhibitor is the first new biologic treatment option for HS patients in nearly a decade.</
- Biosimilar News: YUFLYMA Added to CarePartners Specialty Pharmacy Cost Savings Programshttps://practicaldermatology.com/news/biosimilar-news-yuflyma-added-to-carepartners-specialty-pharmacy-cost-savings-programs/2462100/Celltrion USA, Inc.’s US Food and Drug Administration-approved biosimilar, YUFLYMA (adalimumab-aaty) has been added to CarePartners Specialty Pharmacy Cost Savings Programs. YUFLYMA is a high-concentration (100mg/mL) and citrate-free formulation of the Humira (adal