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 ...

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

The agency maintains that the beta-amyloid-targeting drugs show too limited benefit to justify their cost to the National Health Service.

Archeus hopes to begin a Phase I trial of the PSMA-targeted agent in metastatic, castration-resistant prostate cancer later this year.

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 ...

NEW YORK – The US Food and Drug Administration has given priority review to San Diego-based Kura Oncology and Tokyo-based Kyowa Kirin's new drug application seeking approval for ziftomenib as a ...

Trump administration health officials assured drugmakers and researchers at a roundtable hosted by the FDA that they want to ...

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

Only 6 percent of patients carried a concerning DPYD variant, but nearly two-thirds of them were later hospitalized after ...

The adaptive, biomarker-directed trial allows researchers to enrich for best responders and open new sub-studies for non-responders based on emerging data.

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