The start of the trial marks an expansion of the firm's oncology pipeline, and the firm hopes mRNA-2808 will be the first of many T-cell engagers in its portfolio.

Based on strong preclinical data on HMPL-A251 in HER2-positive tumor cell lines, the firm wants to take the therapy into clinical trials by year end.

The firm, which had planned to submit a BLA in 2026 for AMT-130, described the FDA's latest feedback as a "drastic change" and "unexpected." ...

The Midwest hospital system aims to embed genetic testing into everyday care for heart disease and discover new genetic risk ...

The agency said the move could halve the time it takes for biosimilars to enter the market, drive competition, and reduce ...

The company's outlook for the rest of the year was rosier than in the previous quarter, when it announced a cost-cutting plan ...

The hospital system is betting the move will give it better control over turnaround time and allow it to be more "nimble" in ...

Based on its Q3 performance, the firm raised its full-year sales and EPS guidance and is now expecting sales to be between ...

DMT will use the proceeds to support Phase III development of the gene therapy in wet AMD and diabetic macular edema.

The influential oncology guidelines body revised guidelines with a nod to the FDA's explicit recommendation for testing in Xeloda's label.

The study will test the antibody-drug conjugate in combination with Keytruda in patients with HER2-overexpressing metastatic non-small cell lung cancer.

The clinical hold follows Intellia's disclosure that it paused dosing in two Phase III trials after a patient experienced a serious adverse event.