European Union Grants Marketing Approval for Biogen’s Leqembi® an Amyloid-beta (Aβ) Monoclonal Antibody
Lecanemab is the only approved Aβ monoclonal antibody that binds and clears hazardous protofibrils.
Category: Regulatory
U.S. FDA to Phase Out Animal Testing for the Development of Monoclonal Antibodies and Other Drugs
The FDA’s animal testing requirement will be decreased, modified, or potentially replaced utilizing a variety of methodologies.
U.S. FDA Approved Amgen’s UPLIZNA® (INEBILIZUMAB-CDON) for the Treatment of Rare Immune Disorder
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.
Aldeyra Therapeutics Responds to the U.S. FDA’s Denial of Reproxalap’s NDA Application for Treating Signs and Symptoms of Dry Eye Disease
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’s RSV Lower Respiratory Tract Disease Vaccine ABRYSVO®Approved by European Commission
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 [Read More…]
U.S. FDA Approved Sanofi’s Qfitlia to Treat Hemophilia
In order to help hemophiliacs regain hemostasis, Qfitlia helps boost thrombin production by decreasing AT, a protein that prevents blood clotting.
Eli Lilly Responds to EMA’s Donanemab Marketing Authorization Rejection
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 [Read More…]
U.S. FDA Approved GSK’s Blujepa (gepotidacin) for Treatment of Uncomplicated Urinary Tract Infections (uUTIs) for Female Adults and Paediatric Patients 12 years of Age and Older
Approval based on data from the pivotal phase III EAGLE-2 and EAGLE-3 trials.
Roche’s Supplemental Biologics License Application of Gazyva/Gazyvaro (Obinutuzumab) for The Treatment of Lupus Nephritis Accepted by U.S. FDA
In a randomized phase III study, Gazyva®/Gazyvaro® is the only anti-CD20 monoclonal antibody that shows a full renal response benefit.
Based on Results From the Phase 3 BRUIN CLL-321 trial, Lilly’s Jaypirca (pirtobrutinib) recommended by CHMP for approval in the European Union
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.
