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

More than 30 percent of later-line patients responded to the drug in an existing Phase II trial, but some biomarker cohorts fared better.

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

Waiv, previously operating as Owkin Dx, will expand global access to a pipeline of AI-driven digital pathology and multimodal tests for cancer.

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 Copenhagen-based firm is launching the study at Karolinska University Hospital in Stockholm, Sweden, where it will enroll up to 20 patients who have progressed after chemotherapy and checkpoint ...

The firm is hoping to outline a potential path to accelerated approval for SGT-003 as it gears up to launch a randomized, controlled Phase III trial.