Showing 2101-2110 of 5789 results for "".
- Bimekizumab Update: FDA Still Reviewing UCB's BLAhttps://practicaldermatology.com/news/bimekizumab-update-fda-still-reviewing-ucbs-bla/2461813/The U.S. Food & Drug Administration (FDA) is still reviewing UCB’s Biologics License Application (BLA) for bimekizumab for moderate to severe plaque psoriasis, UCB reports. UCB previously
- CHMP Recommends Approval of Leo's Adtralza Pre-filled 2 mL Penhttps://practicaldermatology.com/news/chmp-recommends-approval-of-leos-adtralza-pre-filled-2-ml-pen-5/2461812/The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) is recommending the approval of Adtralza (tralokinumab) in a (300 mg) 2 mL pre-filled pen. With the pre-filled syringe, a single 300-mg dose given every other week rathe
- Biosimilar News: Optum Rx Lists Cyltezo on Formularyhttps://practicaldermatology.com/news/biosimilar-news-optum-rx-lists-cyltezo-on-formulary/2461805/Optum Rx, a pharmacy benefit manager and subsidiary of UnitedHealth Group, will place Cyltezo (adalimumab-adbm) on its commercial formulary as a preferred brand, Boehringer Ingelheim reports. Cyltezo is a US Food and Drug Administration (FDA)-approved Interchangeable biosimilar to
- Zydus Lifesciences Scores FDA Nod for Generic Acne Drughttps://practicaldermatology.com/news/zydus-lifesciences-scores-fda-nod-for-generic-acne-drug/2461791/The U.S. Food and Drug Administration (FDA) has given its nod to Zydus Lifesciences’ generic antibiotic minocycline hydrochloride extended-release tablets for the treatment of moderate to severe acne in 55 mg, 65 mg, and 115 mg doses, the Company reports. Minocycline hyd
- Sirnaomics Gets FDA Go Ahead to Move STP705 Into Late-Stage Clinical Development for isSCChttps://practicaldermatology.com/news/sirnaomics-gets-fda-go-ahead-to-move-stp705-into-late-stage-clinical-development-for-isscc/2461788/Sirnaomics Ltd.’s STP705 for the treatment of Squamous Cell Carcinoma in situ (isSCC) is moving into late-stage clinical development after encouraging Phase IIa and Phase IIb clinical results. These results were shared with the U.S. Food and Drug Administration (FDA) in an En
- FDA Nod for Avita Medical’s RECELL for Skin Repigmentation in Vitiligo Patientshttps://practicaldermatology.com/news/fda-nod-for-avita-medicals-recell-for-skin-repigmentation-in-vitiligo-patients/2461787/The U.S. Food and Drug Administration (FDA) has approved AVITA Medical, Inc.’s application for premarket approval (PMA) of its RECELL System for the treatment of vitiligo. RECELL for repigmentation of stable depigmented vitiligo lesions is the first FDA-approved therapeutic d
- DFD-29 Shows No Major impact on Healthy Microbial Flora in Rosaceahttps://practicaldermatology.com/news/dfd-29-shows-no-major-impact-on-healthy-microbial-flora-in-rosacea/2461785/DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) doesn’t disrupt the microbial floral in healthy adults with papulopustular rosacea, according to data from a Phase 1 clinical trial. DFD-29 is being developed for the treatment of papulopustular ros
- Cutera's AviClear Scores FDA Nod as Long-Term Acne Treatmenthttps://practicaldermatology.com/news/cuteras-aviclear-scores-fda-nod-as-long-term-acne-treatment/2461784/The U.S. Food and Drug Administration (FDA) has cleared AviClear as a long-term treatment for mild to severe inflammatory acne vulgaris. Cutera’s AviClear initially received FDA clearance for treating acne in March 2022. Now, the FDA has cleared the device for the long
- Merz Aesthetics News: Xeomin Scores in Phase 3 Studies of Upper Facial Lineshttps://practicaldermatology.com/news/merz-aesthetics-news-xeomin-performs-well-in-phase-3-studies-of-upper-facial-lines/2461781/Two pivotal phase 3 clinical studies demonstrated the efficacy and safety of Xeomin (incobotulinumtoxinA) in the simultaneous treatment of horizontal forehead lines, glabellar frown lines, and lateral canthal lines, according to Merz Aesthetics. Merz Aesthetics will submit these data as
- Fall Clinical PAs & NP Update: Castle's DecisionDx-SCC Can Identify Tumors Likely to Spread in Low-Risk CSCChttps://practicaldermatology.com/news/fall-clinical-pas-np-update/2461778/Castle Biosciences, Inc.’s DecisionDx-SCC test can identify tumors likely to metastasize in patients with cutaneous squamous cell carcinoma deemed low risk by traditional staging, according to research presented at the the 2023 Fall Clinical Dermatology Conference for PAs &am