NEW YORK – The US Food and Drug Administration has accepted Roche subsidiary Genentech's new drug application for giredestrant in combination with the mTOR inhibitor Afinitor (everolimus) for estrogen ...

The organization presented data aggregated from multiple clinical trials to explore ctDNA's potential as a surrogate endpoint predictive of treatment benefit in lung and other cancers.

The financing will, in part, support an upcoming Phase IIIb trial of its beleaguered stem cell therapy for amyotrophic lateral sclerosis.

The gene therapy, which was acquired by Novartis in 2023, is also being tested in a separate Phase I/II trial of pediatric ...

The firm will provide manufacturing and regulatory support as UW prepares an IND submission for its GD2 CAR T-cell therapy.

The nonprofit Finding Hope for Frizzle aims to initiate a clinical trial of the gene therapy for FRRS1L disease in the second half of 2026.

The driving force behind the lab was a desire to control biomarker discovery, streamline regulatory approvals for CDx, and develop drugs more cheaply and quickly.

A study evaluated agreement between 10 AI digital pathology tools in assessing IHC-based HER2 expression and found the most variability in identifying HER2-low samples.

The firm said a Phase III trial, comparing adjuvant Retevmo against placebo, met its primary endpoint of event-free survival.

Givastomig is being developed for HER2-negative first-line gastric cancer that expresses CLDN18.2 in combination with Bristol Myers Squibb's checkpoint inhibitor Opdivo (nivolumab) and FOLFOX ...

The drugmaker terminated the first-in-human Phase I/II trial after a year, determining that the clinical data did not support further investigation.