FDA accepts Merck's sac-TMT BLA for priority review, PDUFA date set for June 15, 2027

The FDA accepted Merck's biologics license application for sacituzumab tirumotecan (sac-TMT) for priority review, with a PDUFA date set for June 15, 2027. Merck says sac-TMT reduced the risk of death by 32% and the risk of disease progression or recurrence.

Detected & updated continuously · Source: Nebula