Severe gastrointestinal inflammation could occur in 2 percent to 3 percent of patients who receive Carvykti, the FDA has informed patients and doctors.

The drugmaker said it plans to submit a regulatory application for DB-OTO to the FDA later this year, pending discussions with the agency.

The firm continues to seek needed funds to launch a Phase I/II trial of ELP-02 for this extremely rare form of ...

The initiative comprises academic institutions, charities, and companies pursuing a broad range of novel diagnostic and ...

The company expects top-line results in 2026 from this group of the basket trial testing the drug plixorafenib as a ...

The trial will include up to 78 patients with KRAS G12D-mutant pancreatic, colorectal, and non-small cell lung cancer.

The deal will bolster BMS's cell therapy efforts by adding Orbital's lead program in autoimmune diseases and RNA platform to its portfolio.

NEW YORK – Kernal Biologics on Tuesday said the Advanced Research Projects Agency for Health (ARPA-H) awarded the company up to $48 million to support development of its in vivo mRNA-encoded CAR ...

The grants were awarded under the EMBODY program, which is supporting development of in vivo cell therapy delivery platforms.

Previously, the agency recommended doctors only discuss the risk of adverse events from chemotherapy for those with DPD deficiency.

A retrospective study using data from multiple trials could provide regulators evidence on Ataraxis Breast's ability to predict treatment response.