FDA beoordeelt Roche-aanvraag voor lupusmiddel Gazyva

The US Food and Drug Administration has accepted Roche's application for Gazyva/Gazyvaro as a potential treatment for lupus nephritis, the most common form of lupus. The drug, already approved for certain blood cancers, is now under regulatory review for this new indication. A decision from the FDA is expected following the standard review process.