The FDA’s animal testing requirement will be decreased, modified, or potentially replaced utilizing a variety of methodologies.
Regulatory
IgG4-RD can arise in various organs, causing fibrosis and irreversible organ damage. Understanding how organ damage occurs is key to making an accurate diagnosis of IgG4-RD.
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”.
Pfizer Inc (PFI). announced that the European Commission (EC) has amended the marketing authorization for ABRYSVO®, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to include the prevention of RSV-induced lower respiratory tract disease (LRTD) in people aged 18 to 59. This broadens the prior license for […]
In order to help hemophiliacs regain hemostasis, Qfitlia helps boost thrombin production by decreasing AT, a protein that prevents blood clotting.
Eli Lilly and Company’s (LLY) donanemab is not recommended for marketing authorization for the treatment of early symptomatic Alzheimer’s disease, according to an opinion released by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). Lilly will ask CHMP to re-examine. Europeans living with early symptomatic […]
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.
The European Commission is currently taking final action on the application for the use of Jaypirca in patients with relapsed or refractory CLL who have received prior treatment with a BTK inhibitor as a result of this favorable view.
The first medication approved by the FDA to treat CTX, a rare lipid storage condition, is Ctexli.
