Tag: Drug Approvals
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
FDA Approves Sublingual, Nonopioid Daily Treatment for Fibromyalgia
Tonmya is the first FDA-approved therapy for the treatment of fibromyalgia in more than 15 years
FDA Approves Ketamine Product, KETARx, for Surgical Pain Management
Drugmaker aims to pursue other applications in mental health, neurological, and pain disorders
FDA Approves Ajovy for Migraine Prevention in Children and Teens
Approval is for children and adolescents aged 6 to 17 years weighing ≥45 kg
FDA Approves Vizz Eye Drops to Improve Near Vision in Adults
Trials show once-daily drops are safe and effective
FDA Approves Empaveli for Rare Kidney Diseases
Approval is first treatment for C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis