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 ...
Request for FDA Rolling Review submitted to FDA on January 30, 2026Non-Clinical and CMC BLA modules submitted to FDAAt FDA's ...
Considerable on MSN
Company reaches FDA deal on biomarkers
A healthcare company says it has secured an agreement with the U.S. Food and ...
CHICAGO, Dec. 22, 2025 /PRNewswire/ -- The Prognostic Lung Fibrosis Consortium (PROLIFIC), a collaborative consortium advancing biomarker tools for pulmonary fibrosis (PF) research, announced today ...
Activation of immune blood biomarkers from interferon gamma pathway distinguished long-term survivors (>=2 years) ...
Kamath: Similar to the phase 3 HERIZON-GEA-01 trial, what’s really the overall theme of these is that we have to identify ...
Region-specific biomarkers FGFR4, FLT1, and WNT5A are linked to tumor behavior and therapeutic response in CRC. Comprehensive genomic profiling (CGP) aids in precision medicine by identifying genetic ...
The Forum on Neuroscience and Nervous System Disorders hosted a public workshop on June 21-22, 2010, bringing together key stakeholders, to present promising current and emerging technologies with ...
The key alterations sought are FGFR3 activating mutations or fusions/rearrangements (“susceptible” alterations), for potential use of the FGFR inhibitor erdafitinib (Balversa), and HER2 IHC expression ...
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