Approvable BLAs were associated with significantly longer mean time to first FDA review action: 8.97 versus 7.05 months and with significantly longer mean total review time: 21.3 versus 7.05 months. Issues delaying BLA approvals were qualitatively similar to those delaying NDA approvals. The strategic...
Patritumab deruxtecan is currently being evaluated as both a monotherapy and in combination with other therapies in a global development program, which includes HERTHENA-Lung02, a phase 3 trial evaluating the efficacy and safety of patritumab deruxtecan versus platinum-based chemotherapy in patients...
Number two: prepare for the pre-IND meeting well in advance. Keep in mind that this meeting is the first glimpse that FDA will have of the proposed product, and the meeting will set the tone for future interactions—the importance of making a good first impression cannot be overstated. It ...