GlobalData on MSN

FDA increases manufacturing flexibility for cell and gene therapies

Clinical and commercial quality controls are eased as the FDA looks to expedite therapy approvals in areas of unmet need.
Yahoo Finance

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 ...
WRIC

Transplant Therapeutics Consortium Receives FDA Acceptance of the Qualification Plan for iBox Scoring System

MOUNT LAUREL, N.J., Nov. 20, 2024 /PRNewswire/ -- The American Society of Transplant Surgeons (ASTS) and American Society of Transplantation (AST) announced today that the Transplant Therapeutics ...
Morningstar

FDA Accepts Integral Molecular's Membrane Proteome Array™ Qualification Plan, Advancing the Platform for Approval as a Drug Development Tool

PHILADELPHIA, Feb. 5, 2025 /PRNewswire/ -- Integral Molecular, a leader in antibody discovery technologies, is proud to announce that the FDA has accepted their Membrane Proteome Array™ (MPA) ...
Morningstar

Integral Molecular's Membrane Proteome Array™ Nears FDA Qualification as a Drug Development Tool

MPA on track to become the first NAM approved by the FDA for specificity testing PHILADELPHIA, Oct. 28, 2025 /PRNewswire/ -- Integral Molecular, a leader in antibody discovery and characterization, ...
FOX40 News

Integral Molecular Awarded $2.7 Million to Advance the Membrane Proteome Array™ Towards FDA-Qualification as a Drug Development Tool

PHILADELPHIA, Nov. 19, 2024 /PRNewswire/ -- Integral Molecular, a leader in antibody discovery and characterization, has been awarded $2.7 million by the NIH Commercialization Readiness Pilot (CRP) ...
KXAN

Transplant Therapeutics Consortium Receives FDA Notice of Reviewability for the iBox Scoring System Full Qualification Package

MOUNT LAUREL, N.J., July 30, 2025 /PRNewswire/ -- The American Society of Transplant Surgeons (ASTS) and American Society of Transplantation (AST) announced today that the Transplant Therapeutics ...
MarketWatch

First IPF Biomarker Clears Initial FDA Step Toward Qualification

The MarketWatch News Department was not involved in the creation of this content. CHICAGO, Dec. 22, 2025 /PRNewswire/ -- The Prognostic Lung Fibrosis Consortium (PROLIFIC), a collaborative consortium ...
MarketWatch

Integral Molecular's Membrane Proteome Array(TM) Nears FDA Qualification as a Drug Development Tool

The MarketWatch News Department was not involved in the creation of this content. MPA on track to become the first NAM approved by the FDA for specificity testing PHILADELPHIA, Oct. 28, 2025 ...