SignalFDA/Bio

Capricor outlines BLA amendment plan as FDA signals willingness to review, with PDUFA date set for August 22

FDA signals willingness and PDUFA date set, accelerating Capricor’s BLA amendment timeline.

What changed

FDA signals willingness and PDUFA date set, accelerating Capricor’s BLA amendment timeline.

Why it matters

FDA signals willingness and PDUFA date set, accelerating Capricor’s BLA amendment timeline. — impact context not separately stored; see What changed.

Sources