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 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.
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