Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the approval of STELARA® (ustekinumab) to treat pediatric patients two years and older with moderately to severely active Crohn’s disease. This action could mark the availability of a needed new […]
BLA
AbbVie declared that they had submitted the Biologics License Application (BLA) for trenibotulinumtoxinE (TrenibotE) to the United States FDA for the treatment of moderate to severe glabellar lines. The submission provides evidence of TrenibotE’s differentiated clinical profile to offer patients an opportunity to experience a faster onset and shorter treatment duration as an […]
In a randomized phase III study, Gazyva®/Gazyvaro® is the only anti-CD20 monoclonal antibody that shows a full renal response benefit.
