BioNTech and Roche subsidiary Genentech are discontinuing testing of their jointly developed personalized cancer vaccine in colorectal cancer patients. The companies were testing the mRNA vaccine ...

The firm said it will stop enrolling a late-stage trial in blood cancers to prioritize a preclinical in vivo T-cell receptor program in solid tumors.

For patients with microsatellite instability of mismatch repair deficiency, the final decision cements access to the drug, which was previously offered provisionally.

The firm is testing the next dose level of RV-01 in a Phase I/IIa study after clearance from a safety and monitoring committee.

Regulators approved the FGFR1/2/3 inhibitor based on data showing a 42.5 percent objective response rate and 16.6 months of median overall survival.

NEW YORK – More and more cancer treatments, and now gene therapies, are receiving accelerated approval from the US Food and Drug Administration as sponsors push to get their novel medicines to ...

Jessica Kim Cohen contributed reporting. NEW YORK – After releasing a draft guidance Monday on the "plausible mechanism pathway," outlining how sponsors can bring individualized treatments for rare ...

NEW YORK – Imunon hopes that an interim data readout from a newly launched Phase III trial of its immunotherapy IMNN-001 will allow it to file for the drug's approval in ovarian cancer patients with ...

NEW YORK – Natera and Diakonos Oncology on Friday announced a collaboration to use Natera's circulating tumor DNA (ctDNA) assay Signatera to longitudinally assess molecular response in Diakonos' Phase ...

NEW YORK – Ultragenyx on Thursday said it will lay off about 130 employees, or 10 percent of its workforce, as part of a strategic restructuring plan. Novato, California-based Ultragenyx disclosed the ...

NEW YORK – US Department of Health and Human Services Secretary Robert F. Kennedy Jr. on Tuesday approved the addition of two rare genetic disorders to the Recommended Uniform Screening Panel (RUSP).