Tag: Drug Approvals
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
FDA Picks George Tidmarsh to Head Center for Drug Evaluation and Research
Tidmarsh's areas of expertise include pediatrics, pediatric oncology, and neonatology
Approved-Label Populations for New Drugs Broader Than Trial Populations
Inconsistency seen most often in terms of patient fitness, with variance in almost all approved indications
Kerendia Approved for Heart Failure With Left Ventricular Ejection Fraction ≥40 Percent
Patients taking Kerendia saw significant reduction in cardiovascular death and hospitalization and urgent visits for heart failure
