Tag Archives: Approves

FDA Approves Broadened Indication for Xeomin (incobotulinumtoxinA) as First-Line Treatment for Blepharospasm (Involuntary Blinking) in Adult Patients

Print this page RALEIGH, N.C.  –  May 13,  2019  –  Merz Americas announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Xeomin (incobotulinumtoxinA), broadening its indication to be a first-line treatment of blepharospasm (involuntary blinking) in adult patients. “Merz is proud to offer a first-line… Read More »

Global Health: F.D.A. Approves the First Vaccine for Dengue Fever, but Limits Its Use

The Food and Drug Administration has approved the first vaccine for dengue, Dengvaxia, but placed significant restrictions on its use because the vaccine has been shown to put some people at heightened risk for a severe form of the disease. In clearing the vaccine, the agency acknowledged the serious public health benefit of slowing a… Read More »

FDA Approves Expanded Monotherapy Label for Merck’s Keytruda (pembrolizumab) for First-Line Treatment of NSCLC

Print this page KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not… Read More »