The firm originally submitted the application seeking approval for TLX101-Px in August 2024, but the agency requested additional efficacy analysis.

Sarepta plans to evaluate the gene therapy with a new immunosuppressive regimen in the hopes of relaunching it in the non-ambulatory indication.

The next question researchers want to answer is whether urine-derived lymphocytes can actually help inform responses to ...

The agency previously declined to approve Ebvallo for Epstein-Barr virus-positive post-transplant lymphoproliferative disease and requested a new trial.

NEW YORK – Sellas Life Sciences has enrolled the first patient in a Phase II trial of its CDK9 inhibitor tambiciclib in first-line acute myeloid leukemia (AML), the company announced this week. The ...

NEW YORK – Novartis' key patent on its radioligand therapy Lutathera (lutetium Lu 177 dotatate) isn't set to expire until 2038, but radiopharmaceutical company Lantheus is already preparing to ...

The firm said it expects to file an investigational new drug application for the autologous CAR T-cell therapy TPST-2003 in the US by the end of the year.

The company's clinical development plan comprises three global Phase III studies, including two focused on infants and a third for older patients.

NEW YORK – Multinational artificial intelligence-focused drug discovery and development firm Owkin has spun out a new standalone precision oncology testing company called Waiv, which raised $33 ...