Dallas Observer

Monoclonal Antibodies Treatment for COVID Lags Because of a Lack of Promotion

If you’re older than 12 and test positive for COVID-19, you most likely qualify to receive monoclonal antibody treatment on Texas’ dime. For most, the largest barrier to getting the early-stage ...
Business Wire

Incyte Announces New Positive Data for INCA033989, its First-In-Class mutCALR-Targeted Monoclonal Antibody, in Patients with Myelofibrosis Presented at ASH 2025

WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today announced new clinical data from two Phase 1 studies evaluating the safety, tolerability and efficacy of INCA033989, a first-in-class ...
Business Wire

Incyte’s First-in-Class mutCALR-Targeted Monoclonal Antibody, INCA033989, Granted Breakthrough Therapy Designation by U.S. FDA

The Company plans to initiate a Phase 3 program evaluating INCA033989 in essential thrombocythemia (ET) patients with all types of CALR mutations in mid-2026, following alignment with regulators ...
Reuters

US FDA moves to curtail primate testing in drug trials

Dec 2 (Reuters) - The U.S. Food and Drug Administration on Tuesday issued new draft guidance on reducing the use of lab monkeys in preclinical toxicity studies for certain monoclonal antibodies. The ...
FierceBiotech

FDA issues draft guidance to reduce primate testing for certain antibodies

The FDA has released a plan to stop or reduce the use of primates for testing the safety of certain monoclonal antibodies (mAbs), the latest expansion of the regulator’s efforts to eliminate animal ...
Medical Xpress

Monoclonal antibodies effectively prevent respiratory syncytial virus in infants

Respiratory syncytial virus (RSV) is a common respiratory virus which usually causes mild, cold-like symptoms during the respiratory virus season. However, especially among young infants under six ...
FiercePharma

Syngene: Transforming Monoclonal Antibody Manufacturing for the Next Wave of Biologics

Monoclonal antibodies (mAbs) have revolutionized modern medicine, offering precision therapies for cancer, autoimmune disorders, infectious diseases, and numerous other advantages. The global mAb ...
Medical Xpress

New monoclonal antibody prevents malaria infection in early clinical trial

Malaria remains one of the leading causes of death among children in sub-Saharan Africa, claiming more than 600,000 lives each year worldwide with limited efficacy in currently available treatments ...
Healio

Monoclonal antibody effects persist for 6 months in patients

We were unable to process your request. Please try again later. If you continue to have this issue please contact [email protected]. A one-time subcutaneous administration of GB-0895 ...
MedPage Today

FDA Revokes EUAs of Four COVID-19 Monoclonal Antibodies

The FDA on Friday revoked the emergency use authorizations (EUAs) of four monoclonal antibodies for COVID-19. The four drugs -- bebtelovimab, sotrovimab, casirivimab ...
Scientific American

A Tragic Vaccine Failure Led to a Breakthrough: How Scientists Finally Tamed RSV

This article is part of “Innovations In: RSV,” an editorially independent special report that was produced with financial support from MSD, Sanofi and AstraZeneca. When Laura Ehrlich gave birth to her ...