Eohilia Approved by FDA to Treat Eosinophilic Esophagitis in Patients 11 Years of Age and Older
February 12th 2024Two multicenter, randomized, double-blind, placebo-controlled clinical trials showed that 53.1% of patients administered Eohilia achieved histologic remission compared with 1% of patients administered placebo.
FDA Places Hold on Clinical Trials of Magrolimab for Blood Cancers
February 8th 2024Gilead announced it will discontinue the clinical development of magrolimab for hematologic cancers after the drug in combination with azacitidine plus Venclexta showed an increased risk of death related to infections and respiratory failure in patients with acute myeloid leukemia.
FDA Grants Fast Track Designation to Next-Generation ADC Based on Phase I/II Trial Data
February 6th 2024The ongoing Phase I/II NCT05438329 trial is evaluating BNT325/DB-1305 in patients with platinum-resistant ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer previously administered one to three systemic treatment regimens.
Phase III Trial Data Leads to FDA Priority Review of sBLA for Expanded Indication of Arexvy for RSV
February 6th 2024The supplemental Biologics License Application for Arexvy was based on positive data from the Phase III NCT05590403 trial, which analyzed the immune response and safety of Arexvy in individuals 50-59 years of age with an elevated risk of respiratory syncytial virus-related lower respiratory tract disease.