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Tag: Drug Approvals

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

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