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Tag: Drug Approvals

FDA Approves Tremfya for Pediatric Plaque Psoriasis, Active Psoriatic Arthritis

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40 percent of children achieved complete skin clearance at week 16 with Tremfya versus placebo

FDA Approves Inluriyo for Advanced Breast Cancer

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Approval is for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

FDA Approves Opzelura for Atopic Dermatitis in Children

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It is the first topical JAK inhibitor approved in the U.S. for pediatric atopic dermatitis

FDA Grants Accelerated Approval for First Treatment for Barth Syndrome

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Forzinity helps improve strength of muscle to straighten the leg and works by improving mitochondria structure and function

FDA Approves Subcutaneous Tremfya Induction Treatment for Ulcerative Colitis

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Efficacy and safety found to be similar to intravenous induction

FDA Approves Inlexzo for Bladder Cancer

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First and only drug releasing system is indicated for patients with BCG-unresponsive non-muscle-invasive bladder cancer seeking bladder preservation

FDA Expands Use of Vonvendi for Von Willebrand Disease

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The recombinant treatment is now approved for prophylactic use in adults and for treating bleeding episodes and perioperative use in children

FDA Approves Subcutaneous Leqembi for Treatment of Early Alzheimer Disease

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Leqembi Iqlik allows for at-home maintenance dosing after initial 18 months of intravenous dosing

FDA Approves Papzimeos for Adults With Recurrent Respiratory Papillomatosis

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Papzimeos is the first and only FDA-approved therapy for the treatment of adults with recurrent respiratory papillomatosis

FDA Approves Papzimeos for Adults With Recurrent Respiratory Papillomatosis

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Papzimeos is the first and only FDA-approved therapy for the treatment of adults with recurrent respiratory papillomatosis