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

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

Patients on a perioperative Keytruda regimen saw a 30 percent reduction in the risk of recurrence, progression, or death versus the control arm.

The firm is betting that treatments from new acquisitions, including its recent $12B bid for Avidity Biosciences, will ...

The financing will allow the company to build commercial-grade manufacturing capabilities and make regulatory preparations in the US.

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

The investigator-initiated study will evaluate Create's MT-302 plus chemo with or without standard immunotherapy and anti-HER2 therapy in the first-line setting.

A man with neurofibromas who didn't know he's been clinically diagnosed with NF1, learns he harbors a deeply intronic, likely ...

Amid slow sales, BioMarin will continue to make the gene therapy commercially available in the US, Italy, and Germany while it finalizes next steps.

In the small first-in-human study, AB-1002 showed an encouraging safety profile and early signs of efficacy, investigators ...

In the study, researchers molecularly screened nearly 2,000 cancer patients and matched 14 percent into a study arm.

The drug, JSKN003, showed promising early efficacy in colorectal cancer patients in China in a Phase I/II trial.