Tag: Drug Approvals
FDA Approves Tremfya for Pediatric Plaque Psoriasis, Active Psoriatic Arthritis
40 percent of children achieved complete skin clearance at week 16 with Tremfya versus placebo
FDA Approves Inluriyo for Advanced Breast Cancer
Approval is for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
FDA Approves Opzelura for Atopic Dermatitis in Children
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
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
Efficacy and safety found to be similar to intravenous induction
FDA Approves Inlexzo for Bladder Cancer
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
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
Leqembi Iqlik allows for at-home maintenance dosing after initial 18 months of intravenous dosing
FDA Approves Papzimeos for Adults With Recurrent Respiratory Papillomatosis
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
Papzimeos is the first and only FDA-approved therapy for the treatment of adults with recurrent respiratory papillomatosis