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.

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 ...

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

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

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 ...