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 […]
Regulatory
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.
The U.S. Food and Drug Administration (FDA) has approved GOMEKLI™ (mirdametinib), SpringWorks Therapeutics, Inc.’s MEK inhibitor, for the treatment of adult and pediatric patients with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) that are not amenable to complete resection. SpringWorks Therapeutics, Inc. is a commercial-stage biopharmaceutical company […]
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 […]
