The approval in the second-line EGFR- and MET-altered setting was based on results from the SACHI trial, which compared Orpathys and Tagrisso against chemo.

The company is developing treatments for autism and substance use disorders tailored to patient subgroups identified by clinico-genomic signatures.

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

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

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.