AbbVie declared that they had submitted the Biologics License Application (BLA) for trenibotulinumtoxinE (TrenibotE) to the United States FDA for the treatment of moderate to severe glabellar lines. The submission provides evidence of TrenibotE’s differentiated clinical profile to offer patients an opportunity to experience a faster onset and shorter treatment duration as an […]
Regulatory
Columvi therapy provides a much-needed, off-the-shelf, fixed-duration alternative for transplant ineligible individuals.
Phase 3 tests showing Dupixent dramatically decreased itching and hives when compared to a placebo led to approval.
Lecanemab is the only approved Aβ monoclonal antibody that binds and clears hazardous protofibrils.
The FDA’s animal testing requirement will be decreased, modified, or potentially replaced utilizing a variety of methodologies.
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 […]
