Showing 3141-3150 of 3415 results for "".
- Almirall's Seysara Set to Shake Up US Acne Markethttps://practicaldermatology.com/news/almiralls-seysara-set-to-shake-up-us-acne-market/2457557/The US Food and Drug Administration’s approval of Almirall’s Seysara (sarecycline) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients ages nine and older is set to shake up the currently stagnant acne market due to its ease of adminis
- Ortho Dermatologics Receives Tentative FDA Approval for Bryhali for Plaque Psoriasishttps://practicaldermatology.com/news/ortho-dermatologics-received-tentative-fda-approval-for-bryhali-for-plaque-psoriasis/2457575/The FDA has provided tentative approval of the New Drug Application for Bryhali (halobetasol propionate) Lotion, 0.01%, for the topical treatment of plaque psoriasis in adult patients. Bryhali Lotion is a new potent to superpotent corticosteroid that contains 0.01 percent halobetasol propionate i
- Ortho Dermatologics' Bryhali Lotions Performs Well in Two Phase 3 Psoriasis Trialshttps://practicaldermatology.com/news/ortho-dermatologics-psoriasis-drug-bryhali-performs-well-in-two-phase-3-trials/2457585/Two Phase 3 randomized controlled trials show that Bryhali (halobetasol propionate) Lotion, 0.01%, an investigational potent to superpotent corticosteroid in the treatment of moderate-to-severe plaque psoriasis, is effective and well-tolerated. Bryhali Lotion has a Prescription Drug
- FDA Green Lights First Spray-on-Skin Product for Burnshttps://practicaldermatology.com/news/fda-green-lights-first-spray-on-skin-product-for-burns/2457598/The US Food and Drug Administration granted premarket approval to Avita Medical’s Recell, a spray-on-skin that treats second- and third-degree burns in patients aged older than 18 years. The U.S. market launch for the Recell Autologous Cell Harvesting Device (RECELL® System) is
- New from Thermi: Meet the Arvati Platformhttps://practicaldermatology.com/news/new-from-thermi-meet-the-arvati-platform/2457624/Thermi, an Almirall company, is launching Arvati, a next-generation 510K US Food and Drug Administration-cleared, true temperature-controlled radiofrequency platform that powers a range of Thermi procedures including ThermiTight, ThermiRase, ThermiSmooth Face a
- FDA Accepts Ortho Derm's Resubmission of NDA for Duobrii Lotion for Plaque Psoriasishttps://practicaldermatology.com/news/fda-accepts-ortho-derms-resubmission-of-nda-for-duobrii-lotion-for-plaque-psoriasis/2457630/The FDA has accepted Ortho Dermatologics' resubmitted New Drug Application (NDA) for Duobrii (halobetasol propionate and tazarotene) (IDP-118) Lotion for the topical treatment of plaque psoriasis. The FDA accepted the application as a Class 2 resubmission, with a PDUFA action date of Feb. 15,
- FDA Nod for Ortho Derm's Acne Lotion Altrenohttps://practicaldermatology.com/news/fda-nod-for-ortho-derms-acne-lotion-altreno/2457635/The U.S. Food and Drug Administration (FDA) approved the New Drug Application for Ortho Dermatologic’s Altreno (tretinoin 0.05%) lotion, indicated for the topical treatment of acne vulgaris in patients aged 9 and up. Altreno is expected to be
- Ortho Dermatologics Resubmits NDA for Duobrii Lotionhttps://practicaldermatology.com/news/ortho-dermatologics-resubmits-nda-for-duobrii-lotion/2457646/Ortho Dermatologics, a division of Bausch Health Companies Inc., has resubmitted a New Drug Application (NDA) to the FDA for Duobrii™ (halobetasol propionate and tazarotene; IDP-118) lotion in the treatment of p
- FDA Committee Recommends Approval of Paratek's Omadacyclinehttps://practicaldermatology.com/news/fda-committee-recommends-approval-of-parateks-omadacycline/2457656/The Antimicrobials Drug Advisory Committee of the FDA voted in favor of the approval of intravenous (IV) and oral omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI) (17-1) and community-acquired bacterial pneumonia (CABP) (14-4). Paratek Pharmaceuticals,
- Castle Creek Pharmaceuticals Gets FDA Fast Track Designation for Diacerein 1% Ointment for EBShttps://practicaldermatology.com/news/castle-creek-pharmaceuticals-gets-fda-fast-track-designation-for-diacerein-1-ointment-for-ebs/2457655/The U.S. Food & Drug Administration (FDA) granted fast track status to Castle Creek Pharmaceuticals, LLC’s diacerein 1%, ointment (CCP-020) for the treatment of epidermolysis bullosa simplex (EBS). "Fast Track designation is an