J&J Announces Initiation of New Drug Application with the FDA
Johnson & Johnson has announced the initiation of a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for TAR-200, a treatment for patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. The FDA is reviewing the submission under its Real-Time Oncology Review (RTOR) program, which allows data evaluation to begin prior to the formal submission of the complete application, expediting the availability of potential treatments for patients.
J&J Announces Initiation of New Drug Application with the FDA