Johnson & Johnson JNJ has initiated a rolling submission with the FDA seeking approval for TAR-200, its investigational ...

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 ...

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 bladder ...

The conversion of Calquence’s accelerated approval in mantle cell lymphoma comes a day before the drug was listed among the ...

(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 ...

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 ...