Tag: Drug Approvals
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
FDA Approves Rezdiffra for Nonalcoholic Steatohepatitis
Drug was approved on an 'accelerated' schedule due to pressing medical need
Amtagvi Approved by the FDA for Treatment of Advanced Melanoma
Agency approves one-time cell therapy for patients who have progressed after initial standard-of-care therapies
Expanded Use of Xolair to Treat Food Allergies Approved by the FDA
Xolair is not meant to substitute for emergency anaphylaxis medications such as the EpiPen
