The company established a new protocol for the study and will advance its drug response predictor as a companion diagnostic.

The agency will allow BMS to discontinue REMS programs for both therapies and reduce certain patient monitoring requirements.

A legislative ban on pharma ads, a tool for companies to amplify messaging on drugs, including for precision medicines, is sure to face legal challenges, experts say.

The firm will take a different reimbursement strategy for the test than its prior owner Biocept, which stopped selling it after filing for bankruptcy in 2023.

The therapy, which delivers COL7A1 transgenes by eyedrop, was used previously to treat a patient under a compassionate use protocol.

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

The company said the therapy is the first allogenic therapy developed with its Tmod technology to be tested in humans.

UCLA-led investigators say additional research is needed into why guideline-recommended genetic testing remains low among ...

The agency is considering further regulatory action after a second Duchenne patient died from acute liver failure less than two months after receiving the gene therapy.

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

NEW YORK – Nuvalent is preparing to submit a rolling new drug application to the US Food and Drug Administration, seeking approval for its ROS1 inhibitor zidesamtinib as a treatment for patients with ...

The firm hopes to overcome common dose-limiting toxicities with its PSMA-targeted radiotherapy while boosting potency versus competitors.