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

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

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.

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

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.

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

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

The firm is evaluating two dose levels of its nectin-4-targeted ADC plus Merck's Keytruda in a range of solid tumors.

The firm will evaluate VS-7375 as both monotherapy and in combination with Eli Lilly's EGFR inhibitor Erbitux in the study.