Tag: Drug Approvals
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
FDA Approves Abecma for Relapsed, Refractory Multiple Myeloma
Phase 3 trial shows 51 percent reduction in the risk for disease progression or death in triple-class exposed patients
FDA Approves New Antibiotic for Three Indications
Zevtera approved for S. aureus bloodstream infections, acute bacterial skin/skin structure infections, and bacterial pneumonia
AACR: Little Benefit Seen for Cancer Drugs Given Accelerated Approval
Fewer than half of cancer drugs granted accelerated approval demonstrate clinical benefit
First Gene Therapy for Children With Metachromatic Leukodystrophy Approved by FDA
Approval is for a single-dose gene therapy infusion
