FDA Approves First Single-Dose Generic Treatment for Influenza
The U.S. Food and Drug Administration today approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment…
Regulatory Approvals
FDA Issues Emergency Use Authorization for Drug for Short-Term Prevention of New World Screwworm in Horses
The FDA today issued an Emergency Use Authorization (EUA) for Ivermectin Liquid for Horses (ivermectin oral solution) for the short-term…
FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease
The U.S. Food and Drug Administration today issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged 2 years…
FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer Patients
The U.S. Food and Drug Administration today approved TREGZI, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host…
FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol
The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9),…