J&J files intravesical bladder cancer drug TAR-200 in US
J&J acquired rights to TAR-200 when it bought privately-owned biotech Taris for an undisclosed sum in 2019, and has big sales expectations for the drug, even though it recently failed a second trial in muscle-invasive bladder cancer (MIBC), a potential follow-up indication.
J&J Initiates Bid for FDA Approval of TAR-200 in Bladder Cancer
The New Brunswick, N.J., pharmaceutical giant said the FDA accepted the application through its Real-Time Oncology Review program, which allows for an earlier submission of topline efficacy and safety study results prior to the submission of a complete application to support an earlier start to the agency's review.
Johnson & Johnson Initiates IND Submission Of TAR-200 To Treat High-risk Bladder Cancer
(RTTNews) - Johnson & Johnson (JNJ) Wednesday said it has initiated the submission of new drug application or NDA to Food and Drug Administration (FDA) for TAR-200 to treat patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
Johnson & Johnson Initiates New Drug Application for TAR-200 in BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer
The New Drug Application for TAR-200 is supported by results from the Phase IIb SunRISe-1 study, which demonstrated an 83.5% complete response in patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer.
J&J Seeks FDA Nod for Non-Muscle Invasive Bladder Cancer Drug
Johnson & Johnson JNJ has initiated a rolling submission with the FDA seeking approval for TAR-200, its investigational drug-device combination to treat certain patients with non-muscle invasive bladder cancer (NMIBC).
J&J submits NDA for TAR-200 for bladder cancer
Johnson & Johnson (JNJ) said it has submitted an application to the FDA for its therapy candidate TAR-200 for the treatment of a certain type of bladder cancer. Read more here.
Johnson & Johnson submits NDA with FDA for TAR-200
Johnson & Johnson announced it has initiated the submission of an original New Drug Application with the U.S. FDA for TAR-200 for the
JnJ initiates submission of New Drug Application with USFDA for TAR-200 for BCG-unresponsive high-risk non-muscle-invasive bladder cancer
Raritan: Johnson & Johnson has announced it has initiated the submission of an original New Drug Application with the U.S. Food and Drug Administration (FDA) for TAR-200 for the treatment
Targeted Oncology3d
FDA Considers TAR-200 in BCG-Unresponsive High-Risk NMIBC
An FDA application for TAR-200 to treat BCG-unresponsive high-risk non-muscle-invasive bladder cancer is under real-time ...
BioPharma Dive3d
J&J files a potential blockbuster; Lykos shakes up its board
The pharma began submitting its TAR-200 bladder cancer treatment to the FDA. Elsewhere, Sarepta and Madrigal reported strong ...