PhaseBio Announces Successful Pre-BLA Meeting with U.S. FDA for Bentracimab
PhaseBio recently received formal written minutes from the FDA following its Pre-BLA Meeting held in early April and is expecting to submit its Biologics License Application (BLA) by early in the fourth quarter of 2022 The FDA indicated willingness to accept a BLA with data from 25-30 uncontrolled bleeding patients, in addition to surgical patients … [Read more…]