Articles related to FDA

CARsgen Therapeutics faces a critical juncture as the FDA places a clinical hold on three of its key CAR-T cell therapy candidates, highlighting the paramount importance of manufacturing standards in the realm of advanced oncology treatments.

Belzutifan’s FDA approval, following the LITESPARK-005 trial results, represents a significant stride in treating advanced kidney cancer, offering a novel therapeutic option for patients who have exhausted standard treatments.

An in-depth look at the FDA’s clinical hold on Iovance’s lung cancer cell therapy trial reveals crucial insights into the safety and progression of innovative cancer treatments.

A look into the FDA’s rigorous 2023 drug approval process, including a record number of new medicines and notable rejections. Understanding these trends is essential for anticipating future treatment landscapes.

The FDA’s 2024 agenda navigates the complexities of AI, cybersecurity, and emergency use authorizations, setting the stage for a transformative era in medtech.

The therapy aims to restore progranulin protein levels in the brain, marking a significant step forward in the treatment of neurodegenerative disorders.