In an important milestone for the treatment of hepatitis C, AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved a label expansion of MAVYRET® (glecaprevir/pibrentasvir), its pangenotypic, oral, direct-acting antiviral (DAA) therapy. The new indication now covers adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. This milestone approval distinguishes […]
FDA
Abbott’s Tendyne™ device has secured FDA approval, revolutionizing mitral valve replacement. This minimally invasive system offers a crucial alternative for high-risk patients with severe mitral annular calcification, eliminating the need for open-heart surgery.
Potentially Groundbreaking Treatment Could Delay or Prevent Progression to Full-Blown Myeloma.
The Food and Drug Administration’s approval of lecanemab, a new Alzheimer’s medication shown in clinical trials to reduce the disease slowly over time.
The FDA’s animal testing requirement will be decreased, modified, or potentially replaced utilizing a variety of methodologies.
FDA stated in the letter that the NDA “failed to demonstrate efficacy in adequate and well controlled studies in treating ocular symptoms associated with dry eyes”.
In order to help hemophiliacs regain hemostasis, Qfitlia helps boost thrombin production by decreasing AT, a protein that prevents blood clotting.
Approval based on data from the pivotal phase III EAGLE-2 and EAGLE-3 trials.
In a randomized phase III study, Gazyva®/Gazyvaro® is the only anti-CD20 monoclonal antibody that shows a full renal response benefit.
Teri Boudreaux is thankful for the time she gets to spend with her family, whether it’s hiking, playing with her grandkids, travelling with her spouse, lounging on the beach, or taking up new interests like pickleball. She has survived breast cancer twice. In spite of everything, though, she still harbours […]
