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 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.

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 ...

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

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 ...

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 ...

NEW YORK – In its upcoming Phase I trial in metastatic prostate cancer, Archeus Technologies will look for signs that its investigational radiopharmaceutical ART-101 has greater potency and a more ...