Healio

Q&A: FDA accepts IPF biomarker panel into qualification program

The FDA Center for Drug Evaluation and Research has accepted a letter of intent for the first biomarker for idiopathic pulmonary fibrosis into its Biomarker Qualification Program, according to a press ...
Business Wire

Perspectum Awarded New FDA Grant to Evaluate Biomarker for Rare Disease Drug Development

WASHINGTON--(BUSINESS WIRE)--Perspectum, a leader in medical imaging quantification techniques, today announced that it has been awarded a 2024 U.S. Food and Drug Administration Drug Development Tool ...
Morningstar

First IPF Biomarker Clears Initial FDA Step Toward Qualification

CHICAGO, Dec. 22, 2025 /PRNewswire/ -- The Prognostic Lung Fibrosis Consortium (PROLIFIC), a collaborative consortium advancing biomarker tools for pulmonary fibrosis (PF) research, announced today ...
Medicine Buffalo

FDA-approved screen for Alzheimer’s boost for nursing wet lab

The Food and Drug Administration’s recent approval of a new blood test to aid in the diagnosis of Alzheimer’s disease is a boost for the School of Nursing’s wet lab. The lab, led by nursing researcher ...
Business Wire

U.S. FDA and CEL-SCI Agree on Use of PD-L1 Biomarker to Select Head and Neck Cancer Patients for Marketing Registration Study to Commence Q1 2025

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today announced that in a recent meeting the U.S. Food and Drug Administration (FDA) concurred with the Company’s approach to ...
Medscape

Pharmacogenomic Biomarkers of Susceptibility to Adverse Drug Reactions: Just Around the Corner or Pie in the Sky?

Two overarching goals tied to a futuristic vision of personalized medicine are to maximize individually derived benefits from available therapeutic drugs or biological agents and identify a reliable ...