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.

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.

NEW YORK – A2 Biotherapeutics has treated the first solid tumor patient with its CAR T-cell therapy A2B395 in a Phase I/II clinical trial, the firm announced Thursday.. Agoura Hills, California-based ...

NEW YORK – In a safety communication earlier this week, the US Food and Drug Administration said it is investigating the risk of fatal acute liver failure with Sarepta Therapeutics' Elevidys ...

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

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

NEW YORK – Corbus Pharmaceuticals on Wednesday said it dosed the first patient in the dose-expansion arm of an ongoing clinical trial in which it is evaluating its nectin-4-targeted antibody-drug ...