FDA, Bladder Cancer and Carcinoma in situ
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 announced it has initiated the submission of an original New Drug Application with the U.S. FDA for TAR-200 for the ...
N-Power Medicine, backed by Merck GHI, announced the acquisition of Syapse Holdings. Samsung Biologics and LigaChem extended their ADC services deal. Publicis Worldwide merged with Leo Burnett to form ...
The FDA has granted Priority Review to a Biologics License Application (BLA) for Johnson & Johnson’s (J&J) nipocalimab for the treatment of antibody-positive patients with generalized myasthenia ...
RARITAN, N.J. - Johnson & Johnson (NYSE:JNJ) has begun the process for U.S. Food and Drug Administration (FDA) approval of TAR-200, a new treatment option for high-risk non-muscle-invasive ...
The conversion of Calquence’s accelerated approval in mantle cell lymphoma comes a day before the drug was listed among the ...
Johnson & Johnson announced that the U.S. Food and Drug Administration has granted Fast Track designation to posdinemab, a phosphorylated tau-directed monoclonal antibody being investigated to ...
An FDA application for TAR-200 to treat BCG-unresponsive high-risk non-muscle-invasive bladder cancer is under real-time ...
The FDA has granted priority review to a Biologics License Application for nipocalimab to treat individuals with generalized ...
Biologics License Application acceptance supported by results from the Phase 3 Vivacity-MG3 study Results demonstrate sustained disease control over 24 weeks in a broad ...
Acquisition includes CAPLYTA® (lumateperone), the first and only U.S. FDA-approved treatment for bipolar I and II depression as an adjunctive and ...
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