The Phase 1 GALLOP study evaluating the investigational CAR-T therapy, CB-010, for treatment of lupus nephritis has launched.

In a report released today, Sami Corwin from William Blair maintained a Buy rating on Cabaletta Bio (CABA – Research Report). The company’s ...

The U.S. Food and Drug Administration (FDA) has granted Priority Review to Johnson & Johnson’s Biologics License Application ...

IgG MoDE Degraders: BHV-1300 Phase 1 completing last remaining dose cohorts with the optimized subcutaneous formulation with expected completion in 1H 2025. BHV-1310 first-in-human study anticipated ...

House: Johnson & Johnson has announced the nipocalimab Biologics License Application (BLA) has received Priority Review ...

Spring House, Pennsylvania Saturday, January 11, 2025, 12:00 Hrs [IST] ...

FDA grants priority review tag to JNJ's nipocalimab BLA for gMG and asks for new warnings on GSK & PFE's RSV vaccine labels.

Early treatment escalation to biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) following methotrexate (MTX) failure in new-onset rheumatoid arthritis (RA) does not ...

The application is supported by data from the randomized, double-blind, placebo-controlled phase 3 Vivacity-MG3 study.

The blood test for those at high risk of lung cancer could lead to earlier detection and a "major reduction" in deaths, a ...

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 ...

Johnson & Johnson today announced the nipocalimab Biologics License Application (BLA) received Priority Review designation from the U.S Food and Drug Administration (FDA) for the treatment ...