Showing 1101-1110 of 1555 results for "".
- Biosimilar Update: FDA Nod for High-Concentration, Citrate-Free Formulation of Humira Biosimilarhttps://practicaldermatology.com/news/biosimilar-update-fda-nod-for-high-concentration-citrate-free-formulation-of-humira-biosimilar/2461740/The U.S. Food and Drug Administration (FDA) has approved Yuflyma (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of Humira (adalimumab) biosimilar. The FDA granted approval for the treatment of eight conditions: rheumatoid arthritis, juven
- FDA Nod for Cyltezo Autoinjector Penhttps://practicaldermatology.com/news/fda-nod-for-cyltezo-autoinjector-pen/2461738/The U.S. Food and Drug Administration (FDA) has approved Boehringer Ingelheim’s Cyltezo Pen, a new autoinjector option for Cyltezo (adalimumab-adbm). Cyltezo is an FDA-approved interchangeable biosimilar to Humira (adalimumab). Initially approved as a pre
- Orlucent Receives FDA Breakthrough Device Designation for Handheld Mole Imaging Systemhttps://practicaldermatology.com/news/orlucent-receives-fda-breakthrough-device-designation-for-handheld-mole-imaging-system/2461733/The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Orlucent’s Skin Fluorescence Imaging System. The Orlucent system is a handheld point-of-care molecular-based imaging system designed to noninvasively identify and clinically assess the pres
- FDA Approves First Topical Gene Therapy for Treatment of Wounds in Patients with DEBhttps://practicaldermatology.com/news/fda-approves-first-topical-gene-therapy-for-treatment-of-wounds-in-patients-with-deb/2461732/The U.S. Food and Drug Administration approved Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) g
- FDA Greenlights Phio Pharmaceuticals' Trial of PH-762 in Skin Cancerhttps://practicaldermatology.com/news/fda-greenlights-phio-pharmaceuticals-trial-of-ph-762-in-skin-cancer/2461721/The U.S. Food and Drug Administration (FDA) has cleared Phio Pharmaceuticals’ Investigational New Drug (IND) application to move ahead with a clinical trial of PH-762 for treating skin cancer. PH-762 is an INTASYL compound
- Skinvive by Juvéderm Scores FDA Nod to Improve Skin Smoothness in Cheekshttps://practicaldermatology.com/news/skinvive-by-juvederm-scores-fda-nod-to-improve-skin-smoothness-in-cheeks/2461717/The U.S. Food and Drug Administration gave its nod to Skinvive by Juvéderm to improve skin smoothness of the cheeks in adults over the age of 21. Skinvive by Juvéderm is the first and only hyaluronic acid (HA) intradermal microdroplet injection for skin smoothness availabl
- FDA Set to Review Ortho Derm's Triple Combo Acne Gelhttps://practicaldermatology.com/news/fda-set-to-review-ortho-derms-triple-combo-acne-gel/2461705/The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Ortho Dermatologics’ investigational IDP-126 (clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide 3.1%) Gel. The Prescription Drug User Fee Act (PDUFA) action date is set for October 20, 2023, accordin
- U.S. FDA Grants Breakthrough Therapy Designation to Spevigo for the prevention of GPP Flareshttps://practicaldermatology.com/news/us-fda-grants-breakthrough-therapy-designation-to-spevigo-for-the-prevention-of-gpp-flares-1/2461694/The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation (BTD) to Spevigo for the prevention of generalized pustular psoriasis (GPP) flares, Boehringer Ingelheim reports. This designation follows the Center for Drug Evaluation (CDE) of China National Medic
- Galderma's Sculptra Now FDA Approved for Cheek Wrinkleshttps://practicaldermatology.com/news/galdermas-sculptra-now-fda-approved-for-cheeks/2461683/The U.S. Food and Drug Administration (FDA) has approved Sculptra (injectable poly-L-lactic acid (PLLA-SCA)) for the correction of fine lines and wrinkles in the cheek area. Sculptra is the first FDA-approved PLLA collagen stimulator that helps stimulate natural collagen production in the
- FDA Clears New Underarm Sweat Control Patchhttps://practicaldermatology.com/news/fda-clears-new-underarm-sweat-control-patch/2461660/The U.S. Food and Drug Administration (FDA) has cleared cleared Brella, the first 3-Minute SweatControl Patch to significantly reduce excessive underarm sweating in adults with primary axillary hyperhidrosis. The Brella SweatControl Patch provide