Tag: Drug Approvals
FDA Approves Zoryve for Atopic Dermatitis
The once-daily, nonsteroidal cream is approved for adults and children 6 years and older
FDA Expands Approval for Duchenne Muscular Dystrophy Gene Therapy
Approval allows for use in nonambulatory individuals ≥4 years with a confirmed gene mutation
FDA Expands Pediatric Indication for Rinvoq
Rinvoq can now be used in patients 2 years of age and older with polyarticular juvenile idiopathic arthritis or pediatric psoriatic arthritis
FDA Approves KEYTRUDA + Chemo for Primary Advanced, Recurrent Endometrial Carcinoma
Significant reductions in disease progression or death seen with both mismatch repair-proficient and -deficient cases
FDA Approves Generic Emflaza Oral Suspension for Duchenne Muscular Dystrophy
Approval of deflazacort oral suspension is for patients 5 years of age and older
FDA Approves First Liquid, Nonstimulant ADHD Treatment
The centrally acting alpha2-adrenergic agonist is approved for patients ≥6 years
FDA Approves New Antibiotic for Uncomplicated Urinary Tract Infections
Approval of Pivya is for female adults with UTIs caused by susceptible isolates of E. coli, P. mirabilis, and S. saprophyticus
Alecensa Approved as First and Only ALK Inhibitor for Non-Small Cell Lung Cancer
Drug approved for patients with ALK-positive, early-stage cancer who undergo surgery to remove their tumor
FDA Adds Fasenra Indication for Severe Asthma in Children
Indication is for add-on maintenance treatment of children aged 6 to 11 years with severe eosinophilic asthma
FDA Approves Dovato for Teens Living With HIV
Company says benefit includes fewer antiretroviral medicines, with most patients achieving, maintaining viral suppression
