The agency granted the accelerated approval for Datroway in EGFR-mutant NSCLC based on data from the TROPION-Lung05 and TROPION-Lung01 trials.

The funding comes from the Foundation Fighting Blindness' venture philanthropy arm, the Retinal Degeneration Fund.

Top-line results from a Phase III trial showed an overall survival benefit for zanzalintinib combo therapy in microsatellite-stable colorectal cancer.

For selected applicants, the agency plans to cut review times down to one to two months and provide "tumor board-style" ...

In the growing rare disease precision medicine market, drug companies must avoid funding genetic testing that the Justice ...

NEW YORK – Archeus Technologies on Friday said the US Food and Drug Administration cleared its investigational new drug application (IND) for the theranostic radiopharmaceutical agent ART-101 in ...

Studies doing genome-wide testing can easily ID patients with naturally low neutrophil counts, but nobody's looking at it, ...

NEW YORK – Singapore's Ministry of Health announced this week it will launch a genetic testing program to improve diagnosis of familial hypercholesterolemia (FH) as part of a broader national focus on ...

Lyell Immunopharma announced new clinical data Tuesday from a Phase I/II trial of its dual-targeted CD19/CD20 CAR T-cell therapy for relapsed or refractory large B-cell lymphoma. The company ...

The US subsidiary will focus on advancing PolTreg's pipeline, including its lead candidate PTG-007 in type 1 diabetes, in these new territories.

Medical ethicists are bringing attention to an early chapter of precision medicine history, an often overlooked aspect of an ...

The decision comes as the company is discontinuing clinical testing of a CLDN6-targeted CAR T-cell therapy in testicular cancer.