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.
Category: Regulatory
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.
US FDA Approves Ctexli, First Treatment for Cerebrotendinous Xanthomatosis of Mirum Pharma
The first medication approved by the FDA to treat CTX, a rare lipid storage condition, is Ctexli.
The FDA has approved GOMEKLIâ„¢(mirdametinib) for the treatment of NF1-PN in both adult and pediatric patients, according to SpringWorks Therapeutics
The U.S. Food and Drug Administration (FDA) has approved GOMEKLIâ„¢ (mirdametinib), SpringWorks Therapeutics, Inc.’s MEK inhibitor, for the treatment of adult and pediatric patients with [Read More…]
FDA Approval After Promising Results for Reducing Breast Cancer in Clinical Trials
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, [Read More…]
