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.

Three years after announcing the trial, the company dosed the first patient with the therapy, which targets kappa myeloma antigens.

This marks the company's first study in POLG-mediated primary mitochondrial disease, after completing a Phase I trial in healthy volunteers.

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 ...

NEW YORK – Jazz Pharmaceuticals, a company that sells precision oncology and other therapeutics, on Monday said it plans to purchase Actio Biosciences to expand its rare epilepsy portfolio.

The study partially fulfills a goal set in the company's latest strategic plan that emphasizes late-stage and pivotal trials.

NEW YORK – While the US Food and Drug Administration touts new regulatory flexibility for rare disease drugs, recent rejections of regulatory applications are giving sponsors "whiplash" from mixed ...