Tag: Drug Approvals
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
FDA Approves Eohilia for Eosinophilic Esophagitis
Approval allows for twice daily oral treatment for 12 weeks in people aged 11 years and older
FDA Approves Aurlumyn for Severe Frostbite
Newly approved medication lowers the need for amputation of fingers or toes
FDA Approves Onivyde Combination for Metastatic Pancreatic Cancer
Approval allows Onivyde (plus oxaliplatin, fluorouracil, and leucovorin) as first-line therapy
FDA Approves Ogsiveo for Desmoid Tumors
Approval marks first approved systemic treatment for the rare cancer
FDA Approves First Treatment for Congenital Thrombotic Thrombocytopenic Purpura
The genetically engineered protein product is safe, effective for the rare inherited blood clotting disorder
