The FDA’s animal testing requirement will be decreased, modified, or potentially replaced utilizing a variety of methodologies.
FDA
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 […]
Research establishes foundation for clinical experiment targeted at averting brain tumours in kids with NF1.
Casgevy, one of these treatments, is the first FDA-approved medication to make use of a revolutionary form of genome editing technique
The first oral drug suggested to treat postpartum depression (PPD) in adults, Zurzuvae (zuranolone), has received approval from the U.S. Food and Drug Administration. PPD is a significant depressive episode that can start later in pregnancy but usually starts after delivery. Until recently, the only form of therapy for PPD […]
