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 ...
MM&M2d
Rx Rundown: Johnson & Johnson, Eli Lilly, the FDA and more
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 ...
Johnson & Johnson Strengthens Neuroscience Leadership with Acquisition of Intra-Cellular Therapies, Inc.
Acquisition includes CAPLYTA® (lumateperone), the first and only U.S. FDA-approved treatment for bipolar I and II depression as an adjunctive and ...
Johnson & Johnson Gets FDA Priority Review of Nipocalimab in Generalized Myasthenia Gravis
Johnson & Johnson has won Food and Drug Administration priority review for its application seeking approval of nipocalimab in certain patients with generalized myasthenia gravis.
Johnson & Johnson Gets FDA Fast-Track Designation for Posdinemab in Alzheimer's
The New Brunswick, N.J., pharmaceutical giant said posdinemab has shown potential in targeting disease-associated phosphorylated tau in cerebrospinal fluid from treated Alzheimer's patients, and in ...
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FDA reviews novel bladder cancer treatment from Johnson & Johnson
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 ...
Johnson & Johnson's Posdinemab and Tau Active Immunotherapy Receive U.S. FDA Fast Track Designations for the Treatment of Alzheimer's Disease
Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to posdinemab, a phosphorylated tau-directed monoclonal antibody (mAb) ...
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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 ...
BioSpace1d
AstraZeneca Gets Full FDA Approval for CMS-Selected Lymphoma Treatment
The conversion of Calquence’s accelerated approval in mantle cell lymphoma comes a day before the drug was listed among the ...
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Johnson & Johnson MedTech pauses Varipulse rollout in US
Despite the pause, the company clarified that the suspension does not impact commercial activity outside the US.
Bryan Johnson discontinues longevity drug, after concerns it may have accelerated aging
Bryan Johnson, a tech entrepreneur, has stopped using rapamycin, a drug not approved for anti-aging by the FDA, following ...
Johnson & Johnson: Nipocalimab granted U.S. FDA Priority Review for the treatment of generalized myasthenia gravis
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 ...