TITUSVILLE, N.J. — Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) based on long-term data evaluating the safety and efficacy of CAPLYTA® (lumateperone) for the prevention of relapse in schizophrenia. The data further reinforces the long-term efficacy and tolerability of...

VANCOUVER, Washington — CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including metastatic triple-negative breast cancer (“mTNBC”) and colorectal cancer (“mCRC”), today announced the successful enrollment and initial dosing of...

SPRING HOUSE, Pa. — Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License Application (sBLA) for IMAAVY® (nipocalimab-aahu),c confirming the urgent need for treatment options in warm autoimmune hemolytic anemia (wAIHA). Priority Review is granted to medicines...